Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim). Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major
biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for
biosimilars has propelled growth in contract manufacturing. Some of the
leading contract manufacturing organizations (CMOs) and contract development
and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth
Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over
the recent years, regulatory agencies like the FDA
and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015, FDA has
approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and
Canadian markets, Amgen and Sandoz are tied in the first place
with 13 approved biosimilars each. Samsung Biologics has nine approved
biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one
being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it
netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11
drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to
Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first
interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to
Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 — down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable
biosimilars this year. Interchangeable biosimilars meet additional requirements
and may be substituted for its reference product by a pharmacist without
consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer
drug denosumab (Prolia and Xgeva) in
Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars
for eye drug aflibercept (Eylea) in Opuviz and
Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5
trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two
percent of prescriptions, they account for 46 percent of all pharmaceutical
spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4
billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US
savings are projected to reach US$ 181 billion through 2027. Between 2026
and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop
19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung
Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April
and May of this year, respectively.Opdivo (nivolumab), belonging to the same
class of drugs, competes with Keytruda and is also set to lose patent
protection in 2028. It hauled in US$ 10 billion in total global sales in 2023
for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between
2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith
over 2 billion people worldwide unable to access life-saving medicines,
biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira. In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.
Impressions: 1481
The pharma industry clearly recalibrated itself in 2023, turning its focus away from Covid and onto two of the biggest threats to human health – obesity and cancer. The top lines of the major pharma companies reflect this shift in focus.We
always knew that Pfizer’s record US$ 100 billion revenue for 2022 wasn’t sustainable. Even though Pfizer’s 2023 sales were lower by nearly 42 percent against its 2022 sales, the New York-headquartered drugmaker managed to retain its pole position. The two main reasons behind its ‘top of the charts’ sales of US$ 58.5 billion were Pfizer’s record nine new molecular entity approvals by the US
Food and Drug Administration (FDA) and the launch of its vaccine for
respiratory syncytial virus (RSV).Johnson & Johnson came second with sales of US$ 54.8
billion (excluding its consumer business and MedTech units). AbbVie took bronze despite Humira being subject to biosimilar competition
and Merck maintained its fourth position. Roche nabbed the fifth position from Novartis (which stood sixth). Bristol Myers Squibb maintained its position at seven, as did
AstraZeneca (eighth) and Sanofi (ninth). And Eli Lilly bumped into the tenth spot, knocking out
GSK.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available)Keytruda, Eliquis, Humira top charts; Novo’s Ozempic debuts top 10 list at number fourMerck’s Keytruda became the number one selling drug in the world, a position that was held
by AbbVie’s Humira for long, and Pfizer’s Comirnaty in the Covid years. This
oncology drug raked in a whopping US$ 25 billion, with sales increasing 19 percent last
year. In fact, Keytruda accounted for 46.7 percent of Merck’s pharmaceutical sales, which grew 3 percent in 2023 to US$ 53.6 billion.At number two was
Pfizer and BMS’ anticoagulant Eliquis — it posted global sales of US$
18.95 billion (marking a
growth of 4
percent on 2022 sales). With
competition from generics, Humira’s sales fell by 32 percent to US$ 14.5 billion. As a result, this
blockbuster anti-rheumatic drug fell to the third rank.The
fourth spot was taken up by Novo Nordisk’s Ozempic, the wonder drug that treats type 2
diabetes. Gilead’s Biktarvy, a med that treats HIV-1, saw sales jump 14 percent — from US$ 10.39 billion posted in 2022 to US$ 11.85 billion last year. This way, Biktarvy emerged as
the fifth largest selling drug of 2023.At
number six was Sanofi and Regeneron’s Dupixent. This allergic diseases med posted
11-figure sales in 2023, netting € 10.72 billion (US$ 11.59 billion) globally, a growth of 34 percent over
2022 numbers.At
number seven was J&J’s biggest blockbuster immunology drug Stelara that raked in US$ 11.3 billion in 2023. Coming a close eighth was Pfizer-BioNTech’s Covid-19 vaccine Comirnaty — its sales fell by over 70 percent to US$ 11.22 billion in 2023. At the ninth spot was Lilly and Boehringer’s diabetes drug Jardiance that saw a 27.7 percent increase in
total global sales at US$ 10.6 billion. And rounding off the list at number 10
is BMS’s Opdivo, a Keytruda rival. Opdivo hauled in US$ 10 billion
in total global sales in 2023, a year-on-year increase of 8 percent.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available)Driven by diabetes, obesity care meds,
Novo, Lilly post double-digit sales growthDemand
for diabetes and new weight-loss drugs catapulted Novo Nordisk to emerge as the most valuable public
company in Europe. Its net sales zoomed 31 percent to DKK 232.3 billion (US$ 33.75 billion) compared to DKK 177
billion (US$ 25.8 billion) in 2022. Net profit jumped 51 percent to DKK 83.68 billion (US$ 12.51 billion) in 2023 from DKK
55.5 billion (US$ 8.32
billion) in 2022 — the highest annual profit for the Danish drugmaker in over three decades.The
growth was driven by Ozempic, whose sales spiked 60 percent in 2023
to DKK 95.7 billion (US$ 13.91 billion), from DKK 59.8 billion (US$ 8.71 billion) the
year before.Rival
Eli Lilly’s revenue grew 20 percent in 2023 to US$ 34.1 billion from US$ 28.5 billion in 2022. Mounjaro turned out to be a star for the
Indianapolis drugmaker with its sales rocketing 970 percent in 2023 to US$ 5.16 billion. FDA also approved it to treat obesity
under the brand name Zepbound in November, which brought in additional
revenues of US$ 176 million.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available) GSK’s RSV jab makes strong debut; AbbVie’s immunology drugs post steep growthGSK’s Arexvy was the first RSV vaccine approved by the FDA. It made a strong debut — Arexvy contributed £ 1.2 billion (US$ 1.5 billion) to GSK’s sales in just four months.AbbVie posted another solid financial year.
Though the drop in Humira revenue was offset by two newer
immunology blockbuster drugs, Skyrizi and Rinvoq, the Illinois-headquartered drugmaker
did posted a marginal decrease in revenue of 6.4 percent to US$ 54.3 billion. However, revenue from Skyrizi soared 50 percent to US$ 7.8 billion,
while Rinvoq’s sales increased 57 percent to US$ 4
billion. AbbVie expects a combined US$ 16 billion from Skyrizi (US$ 10.5 billion) and Rinvoq (US$ 5.5 billion) sales in 2024. BMS attributed its 2 percent decrease in
revenue (of US$ 45 billion) to lower sales of Revlimid in the US due to competition from
generics. Sales of the multiple myeloma treatment dropped 39 percent to US$ 6.1
billion. Ophthalmology drug Eylea saw a drop in sales of
4 percent, at US$ 9.21 billion (from US$ 9.65 billion), as competition from Roche’s Vabysmo triggered a price cut by Regeneron. Vabysmo saw sales balloon 324 percent
from CHF 591 million (US$ 685.56 million) to CHF 2.4 billion (US$ 2.78 billion) in 2023.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available) Our viewAccording
to data analytics company GlobalData, GLP-1 agonist drugs (such as Ozempic and Mounjaro that treat type 2 diabetes) are slated to overtake PD-1 antagonists (such as oncology drugs
Keytruda and Opdivo) as the top-selling drugs on the market
in 2024. It estimates a robust compounded annual growth rate (CAGR) of 19.2
percent from 2023 to 2029 for GLP-1 drugs that seem to have more benefits
besides bringing down blood sugar levels (such as weight management, benefits
to the heart etc).The
market size for GLP-1 is likely to increase to US$ 105 billion by 2029. In
contrast, the data firm projects a CAGR of 4.7 percent in the PD-1 antagonist
market, with its market size projected to be around US$ 51 billion in 2029.
Given these projections, we are likely to see more movers and shakers in our
top 10 drug list this year.
Impressions: 3057
After a year when
drug approvals by the US Food and Drug Administration
(FDA) slipped to the lowest since 2016, the first half of 2023 (H1 2023) saw a
62.5 percent growth in drug approvals by the Center for Drug Evaluation and Research (CDER) as compared with the same period last year. FDA’s CDER approved 26 new drugs
in 2023, up from 16 in H1 2022. Approvals of biologics by the FDA surpassed full-year totals for many of the past 20 years. Nine new biologics were approved by FDA’s Center for Biologics Evaluation and Research (CBER) in H1 2023, as against just eight
for 2022.While FDA approved more drugs, authorizations by the European Medicines Agency (EMA) also increased but drug approvals by Health Canada dipped by approximately 50 percent. In the first half of 2023, EMA authorized 14 drugs, as opposed to 10 in H1 2022. Similarly, Health Canada approved 13 drugs against 25 in H1 2022.Among the
promising drugs approved in H1 2023 are Biogen and Eisai’s Alzheimer’s drug Leqembi (lecanemab), Astellas Pharma’s drug for hot flashes (associated with
menopause) Veozah, AbbVie and Genmab’s blood cancer drug Epkinly and, GSK and Pfizer’s RSV vaccines Arexvy and Abrysvo, respectively.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available)GSK, Pfizer’s RSV vaccines to generate over US$ 1 billion by 2028The highlight of H1 2023 has been the approval of vaccines for respiratory syncytial virus (RSV), a contagious virus that causes infections of the respiratory tract, and can cause severe illness in older adults and infants. In May 2023, FDA approved GSK’s Arexvy, respiratory syncytial virus (RSV) vaccine for people aged 60 and older, making it the first vaccine approved in the US that protects against the disease. The drug is expected to generate US$ 1.73 billion in peak sales by 2028.Weeks later, the agency approved Pfizer’s Abrysvo, another RSV vaccine for older adults. The vaccine is expected to be available
in the third quarter of 2023. In late August, Pfizer also bagged an FDA nod for
use of Abrysvo to prevent RSV in infants by vaccinating pregnant women. The
drug is expected to generate US$ 1.31 billion in peak sales by 2028.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) Leqembi, Veozah, Epkinly likely to join ‘over US$ 1 billion club’ by 2028In March, the US health regulator suggested stricter trials for accelerated approval of cancer drugs. The proposed recommendation followed criticism over the approval of Biogen and Eisai’s Alzheimer’s treatment Aduhelm through this pathway in June 2021.Contrary to this
stand though, FDA had approved another Alzheimer’s drug from Biogen and Eisai — Leqembi (lecanemab) — through the same pathway in January 2023. Leqembi is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. The drug is expected to generate US$ 1.9 billion in peak sales by 2028. Later in July, FDA expanded the accelerated approval of lecanemab to a traditional approval for early-stage Alzheimer’s disease.The US regulator
approved several potential blockbuster drugs during the month of May. It
granted full approval to Pfizer’s Covid-19 oral antiviral pill Paxlovid (nirmatrelvir and ritonavir) during the month, which had been
granted an emergency use authorization during the heydays of the pandemic. Paxlovid is the first oral antiviral pill for Covid-19. With the pandemic behind us, Paxlovid’s sales have been waning, though it is still projected to yield approximately US$ 5.5 billion in sales by 2028.The other
important drug approved in May is Japanese drugmaker Astellas Pharma’s oral drug Veozah (fezolinetant) for the treatment of moderate to severe vasomotor symptoms (VMS), or hot flashes associated with menopause. The drug will cost US$ 550 for a month’s supply. Veozah is expected to generate US$ 1.9 billion in sales by 2028.FDA also granted
accelerated approval to AbbVie and Genmab’s blood cancer therapy Epkinly (Epcoritamab-Bysp) in May. It
has bagged approval to treat patients with diffuse large B-cell lymphoma
(DLBCL), and is likely to emerge as a US$ 1.1 billion product.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) Sarepta, Biomarin’s gene therapies bag FDA nod; Lilly’s Jaypirca okayed for lymphomaIn June, FDA
approved Sarepta’s Elevidys and Biomarin’s Roctavian. Elevidys bagged accelerated approval in Duchenne muscular dystrophy (DMD)
patients aged four to five years. This is the first gene therapy approved by
the FDA for the treatment of certain patients with DMD. Elevidys is expected to
generate US$ 3.36 billion in peak sales by 2028.BioMarin’s one-time gene therapy – Roctavian – has been approved by the FDA to treat severe hemophilia A, a
rare bleeding disorder. Priced at US$ 2.9 million, Roctavian is the first gene
replacement therapy to be approved for the condition. Roctavian is expected to
generate US$ 1.43 billion in peak sales by 2028. This approval follows another
approval granted in November 2022 for the first gene therapy to treat adults with hemophilia B — CSL Behring and uniQure’s Hemgenix.In January, Lilly’s Jaypirca (pirtobrutinib) bagged FDA nod, thereby becoming the first and only non-covalent, BTK Inhibitor for the
treatment of adult patients with relapsed mantle cell lymphoma which did not
respond to other BTK Inhibitors. Jaypirca is expected to generate US$ 0.91
billion in peak sales by 2028.In March, FDA approved Pfizer’s Zavzpret (zavegepant) as the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine. Zavzpret is expected to generate US$ 0.649 billion in peak sales by 2028.Another important FDA approval was granted to GSK’s drug Jesduvroq — it is now the first oral treatment for anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) FDA rejects Lilly’s donanemab, Alvotech/Teva’s Humira biosimilarIn January, when
the FDA had approved Leqembi, the agency had rejected Eli Lilly’s bid for an accelerated approval pathway for its experimental Alzheimer’s disease drug donanemab. The agency had cited a lack of participants who received continuous treatment with donanemab for at least 12 months as the reason for its decision. However, Lilly
announced positive late-stage trial
results on donanemab in July — it slowed cognitive decline by 35 percent compared to a placebo in a late-stage trial. An FDA decision on the drug is likely around 2023-end or in early 2024.Similarly, FDA turned down Lilly’s mirikizumab for the treatment of ulcerative colitis. The agency also rejected a BLA for Eli Lilly’s ulcerative colitis drug mirikizumab over manufacturing concerns. Besides these, FDA also rejected Alvotech/Teva’s Humira biosimilar — AVT02 — for a second time this year.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) Our viewAfter the
pandemic, business is back to normal at the FDA. The number of CDER approvals
in the first half of this year are approximately 70 percent of the approvals in
2022. We anticipate more approvals in the upcoming months. If the FDA sustains
this pace, approvals this year could potentially double those of the previous
years.
Impressions: 3549
Over the last five years, a
lot has changed for Pfizer Inc, one of the world’s leading pharmaceutical companies based on pharma sales revenue. From entering into an agreement with German biotechnology company BioNTech SE in August 2018 for joint research
and development of mRNA-based influenza vaccines to merging its off-patent
branded and generic drug business, known as Upjohn, with Mylan to form Viatris and launching
Covid-19 vaccine Comirnaty and antiviral drug Paxlovid during the pandemic,
the New York-headquartered pharma giant has witnessed substantial
transformation in the recent past.The launch of Covid products was
undoubtedly the biggest event for the 174-year-old drugmaker, propelling it to the number 1 slot in 2021 with a turnover of US$ 81.3 billion, surpassing competitors such as AbbVie, Johnson & Johnson, Novartis, Roche, Bristol Myers Squibb, Merck, and several others. In 2022, Pfizer further consolidated its position, with revenues exceeding US$ 100 billion, largely due to the success of its Covid products. This success of Covid products filled Pfizer’s coffers, allowing it to expand through the acquisition of smaller companies. Pfizer’s new brand identity and logo,
unveiled in 2021, signaled the company's shift from "commerce to science".Pfizer commercially operates through two segments — Biopharma, or its innovative science-based biopharmaceutical business that posted revenues worth US$ 98.98 billion in 2022, and Pfizer CentreOne (PC1),
a global contract development and manufacturing organization as well as a
leading supplier of specialty active pharmaceutical ingredients (APIs) with US$ 1.3 billion in 2022 revenues.Pfizer’s core therapeutic areas are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines and anti-infectives.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel)Pfizer in acquisition overdrive: Buys Seagen for US$ 43 bn, Biohaven for
US$ 11.6 bnPfizer has been utilizing its
war chest generated during the pandemic in acquiring companies that would help
grow the business when Covid is behind us and its other best-selling drugs
(such as Ibrance, Vyndaqel/Vyndamax, Xeljanz and Xtandi) face expiration of patents. In November 2021, Pfizer snapped
up Trillium Therapeutics for US$ 2.22 billion. Trillium is a
clinical stage immuno-oncology company developing innovative therapies for the
treatment of cancer. In March 2022, Pfizer acquired
Arena Pharmaceuticals for US$ 6.7 billion, a company that
develops novel therapies to treat immune-inflammatory ailments. Then, in Oct 2022 it completed the US$ 11.6 billion buyout of migraine specialist Biohaven. This brought Biohaven’s leading oral migraine drug in the US – Nurtec ODT (rimegepant) – into Pfizer’s fold. In June 2022, Pfizer completed the acquisition of ReViral Limited, gaining access to
its experimental drugs used to combat respiratory syncytial virus (RSV)
infections. In October, Pfizer paid US$ 5.4 billion for blood disorder
drugmaker Global Blood Therapeutics (GBT). Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – to its portfolio.And this month, Pfizer
announced it will acquire Seattle-based cancer specialist Seagen for US$ 43 billion, its biggest acquisition in the recent past. “We are not buying the golden eggs,” Albert Bourla, CEO of Pfizer, said post the announcement. “We are acquiring the goose that is laying the golden eggs.”The Pfizer-Seagen deal is
also the largest biopharma acquisition since 2019, when BMS bought Celgene for US$ 74 billion. Seagen is a leader
in antibody-drug conjugate (ADC) technology. This deal will bring four
commercial medicines (Adcetris, Padcev, Tukysa and Tivdak) and a deep pipeline of ADC candidates to Pfizer’s fold.Seagen is likely to post US$
2.2 billion in revenues this year, which is expected to grow to over
US$ 10 billion (risk-adjusted) by 2030. Earlier this year, Bourla had said the company has planned to use its “extraordinary firepower” to buy products that will deliver US$ 25 billion in
incremental revenue by 2030. While Seagen will
bring in US$ 10 billion, another US$ 10.5 billion will come from Arena,
Biohaven, GBT and ReViral.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Diminishing demand for Covid products, expiring patents to drag turnover
downPfizer’s turnover has nearly doubled since 2018, when it was at US$ 53.6 billion. In July 2019,
Pfizer had announced the plan to combine
Upjohn with Mylan to form a new company — Viatris. With the separation of the Upjohn business and the formation of a consumer healthcare joint venture with GSK in 2019, Pfizer
transformed into a more focused player in innovative medicines and vaccines.
However, this restructuring measure also
led to a drop in its turnover to US$ 51.8 billion in 2019 and to US$ 41.9 billion in 2020. From the number three slot in 2018 (behind J&J and Roche), Pfizer’s ranking fell to eight in 2020.
However, Covid turned its fortunes yet again and its turnover increased to US$
81.3 billion in 2021.When we split Pfizer’s 2022 revenues of US$ 100.3 billion, we notice that its
portfolio has 10 products with sales greater
than US$ 1 billion. These include the Covid-19 vaccine Comirnaty with US$ 37.8
billion in revenues, Paxlovid with US$ 18.9 billion, anticoagulant Eliquis with US$ 6.5
billion, and the Prevnar family of pneumococcal vaccines with US$ 6.3 billion
in revenues. Pfizer's partner BMS recorded sales of US$ 11.8 billion for Eliquis in 2022.With a drop in Covid cases,
demand for Comirnaty and Paxlovid has decreased significantly. In 2023,
Comirnaty’s revenue is likely to drop 64 percent to around US$ 13.5 billion, and Paxlovid’s revenue is likely to plummet by around 58 percent to around US$ 8 billion.Pfizer expects its 2023
revenues to be between US$ 67 billion and US$ 71 billion, reflecting an
operational decline of over 30 percent. However, when we exclude the revenues
of Covid products, we are likely to see a growth in revenues of around 7 to 9 percent, coming primarily from new product launches, recently acquired products and Pfizer’s in-line portfolio.“Pfizer expects 2024 sales of Covid products to stabilize, then starting in 2025 and continuing in
2026 and beyond, it expects to see an increase in Covid-19 vaccination rates, assuming the successful development and approval of a Covid-flu combination product,” said Bourla. Last December, Pfizer and BioNTech received fast track designation from the US Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and Covid-19, which aims to help prevent two respiratory diseases with a single injection.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Stars in Pfizer’s pipeline — RSV, pneumococcal and meningococcal vaccinesIn 2022, Pfizer spent US$ 11.4 billion in research and development, up 12 percent from its R&D spend in 2021. It has a power-packed pipeline with 110 programs, including 72 new molecular entities. Out of the 110 programs, 33 are in oncology, 23 in inflammation and immunology, 19 in vaccines, 15 in internal medicines, 12 in rare diseases and eight in anti-infectives.However, the stars in Pfizer’s pipeline are its vaccine candidates. Pfizer’s RSV vaccine candidate RSVpreF is being developed for pregnant women (to help protect their babies from RSV after birth) and individuals 60 years of age or older for the prevention of lower respiratory tract disease caused by RSV. The vaccine recently received support from the FDA's advisory committee, and a decision on its use for older adults is expected by May 2023.The agency has also granted
priority review to the maternal RSV vaccine, with an action date of August
2023. If approved, it would be the first vaccine for pregnant women
to help protect against the complications of RSV disease in infants from birth
through six months.Recently, FDA also designated
Prevnar 20 for priority review in children aged six weeks through 17 years. Six months ago, Merck’s Vaxneuvance had received pediatric approval. The Merck vaccine defends against 15 serotypes, as compared to 13 strains covered by Pfizer’s Prevnar. However, Merck’s edge could be short-lived as Prevnar’s next-generation vaccine protects against 20 serotypes. The US regulatory agency has also accepted the BLA (biologics license application) review of Pfizer’s pentavalent meningococcal vaccine candidate — MenABCWY — in adolescents with the PDUFA date of October 2023. Moreover, the
company has announced positive top-line results from a phase 3 study of
its hemophilia B gene therapy candidate, fidanacogene elaparvovec.Besides this vaccines and
therapies, FDA is going to decide on several other Pfizer drugs in 2023, such
as ritlecitinib for alopecia,
elranatamab for multiple myeloma, etrasimod for ulcerative
colitis, and Abrilada, a biosimilar of AbbVie’s blockbuster Humira (adalimumab).View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Our viewAs of today, the sweet spot of US$ 100.3 billion in 2022 revenues posted by Pfizer surely looks like a one-off. Though the drug behemoth’s vaccine pipeline looks promising, its shopping list reflects a huge reliance on oncology for future growth.While only time can tell which of those bets will work and which won’t, it looks like Pfizer has capitalized on the lead the pandemic granted it to race ahead of competition.(All financial and drug pipeline-related information has been taken from the Pfizer website.)
Impressions: 2870
The pandemic years haven’t been great for dealmaking. Our analysis of top 10 biopharma M&A transactions shows that after a blockbuster 2019, when the combined value of top 10 biopharma M&A transactions had hit US$ 207 billion, M&A activity decreased in the next two pandemic years, with the combined value of top 10 deals dropping to US$ 97 billion in 2020 and to US$ 53 billion in 2021.In 2022, the combined value of the top 10 M&A transactions reached US$ 69 billion. However, our analysis shows that total M&As increased only marginally — from US$ 93.6 billion in 2021 to US$ 98.7 billion in 2022. In fact, the total M&As by upfront cash dropped from US$ 77.6 billion to US$ 76.3 billion. Our data does not include deals in medical devices, diagnostics and animal health.Industry watchers had predicted 2022 to be the year of M&As, as Big Pharma were expected to spend the booty amassed during the pandemic on acquisitions. But record inflation, a looming recession, the ongoing Russia-Ukraine war, volatile stock markets and some regulatory moves (such as the US Inflation Reduction Act) deterred companies from loosening their purse strings.The result was another
lackluster year for M&As. The top 10 M&A deals in 2022, selected based on upfront cash paid,
include Amgen’s Horizon takeover (US$ 27.8 billion), Pfizer’s purchase of Biohaven (US$ 11.6 billion) and Global Blood Therapeutics (US$ 5.4 billion), and BMS’ purchase of Turning Point Therapeutics (US$ 4.1 billion).View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available)Amgen buys Horizon in 2022’s biggest deal; picks up ChemoCentryx for US$ 3.7 bnThe year began on a sluggish note with M&A activity picking up in the second half. The biggest deal of the year — Amgen’s acquisition of Horizon Therapeutics — came in December.Last November, Horizon Therapeutics had said it
had drawn
buyout interest from players like Amgen, Sanofi and Johnson
& Johnson. Just weeks before Christmas, Amgen announced its US$ 27.8 billion takeover of Horizon. The Irish firm develops medicines for rare autoimmune and severe inflammatory diseases mostly sold in the US. Once complete, the deal will give Amgen access to Horizon’s two best-selling drugs – thyroid eye disease drug Tepezza and gout
treatment Krystexxa. Owing to the Amgen-Horizon deal, the rare
diseases therapeutic area attracted the highest amount of M&As (by deal
size). The second largest was neurology, with Pfizer taking over Biohaven and UCB
Pharma acquiring Zogenix.In August, Amgen had picked up Californian
biotech ChemoCentryx for US$ 3.7
billion to help broaden its portfolio of inflammation and kidney drugs. The deal brought ChemoCentryx’s potential blockbuster treatment for inflammatory disorders — Tavneos (avacopan) — into Amgen’s fold, along with three early-stage drug candidates that target ulcerative colitis, skin conditions and cancer.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Pfizer acquires Biohaven for US$ 11.6 bn, Global Blood Therapeutics for
US$ 5.4 bnThe pandemic brought huge
revenue gains for Pfizer and the drug
behemoth decided to use the cash by cherry-picking companies that would
strengthen its portfolio. In May, Pfizer notched up New Haven-based Biohaven
Pharmaceuticals for US$ 11.6 billion. The deal gave
Pfizer the rights to Nurtec ODT, a leading oral migraine drug in the US and a potential blockbuster. Biohaven has six other migraine drugs in development and Pfizer expects them to top US$ 6 billion in annual sales. Biohaven is Pfizer’s largest purchase since 2016, when it bought Medivation for US$ 14 billion.Later in the year, Pfizer
acquired blood disorder drugmaker Global Blood Therapeutics (GBT) for US$ 5.4 billion with the intention of expanding its sickle cell disease portfolio. Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – into its portfolio. Pfizer expects all these blood disorder drugs to contribute US$ 3 billion in peak sales.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) BMS buys Turning Point for its oncology pipeline; Takeda acquires Nimbus
LakshmiIn June, Bristol Myers Squibb acquired California-based drug developer Turning Point Therapeutics for an upfront
cash amount of US$ 4.1 billion to bolster its cancer drug pipeline. The deal gives BMS access to Turning Point’s star candidate, repotrectinib, in trials to treat non-small cell lung cancer (NSCLC) along with other advanced solid tumors. BMS expects repotrectinib to be approved in the US in the second half of 2023 and become a standard-of-care therapy for certain patients with NSCLC.In December, Takeda Pharmaceutical acquired US-based Nimbus
Lakshmi, a subsidiary of Nimbus Therapeutics that works
on TYK2 programs, for US$ 4 billion in upfront payment. Through the deal, Takeda won Nimbus’ experimental psoriasis drug TAK-279. Takeda will make two milestone payments of US$ 1 billion each to Nimbus if TAK-279 achieves annual net sales of US$ 4 billion and US$ 5 billion.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) GSK enters pneumococcal vaccine race with Affinivax deal; UCB buys ZogenixGSK – one of the world’s largest vaccine makers by sales – is set to compete for a share of the lucrative pneumococcal vaccine market with its purchase of Affinivax for a potential US$ 3.3 billion. Through the deal, the British drugmaker has gained access to the Boston-based biopharma’s 24-valent pneumococcal vaccine candidate, along with its vaccine development technology platform MAPS (Multiple Antigen Presenting System) and other assets. GSK believes the vaccine candidate will help it challenge market leader Pfizer’s blockbuster Prevnar range of vaccines.GSK also paid US$ 1.9 billion for American drug
developer Sierra Oncology and gained access to the latter’s targeted therapies for the treatment of rare forms of cancer. Sierra’s lead candidate momelotinib is being developed to address the unmet medical needs of anemic myelofibrosis patients. GSK believes the drug will work better at treating anemia than the currently approved JAK inhibitors on the market. FDA will decide on the drug’s approval by June 2023.Belgian biopharma UCB paid US$ 1.9 billion for Zogenix, expanding its
portfolio of treatments for specific and rare forms of epilepsy drugs. The
acquisition will help UCB deepen its foothold in the epilepsy market, adding to
its existing line of four products, including Vimpat and Briviact.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Merck inks deal with Kelun Biotech; Regeneron buys rights to Sanofi’s cancer drugSeveral drugmakers announced
collaborations where milestone payments took precedence over upfront payments.
In one such deal, Merck entered into a
potential US$ 9.3 billion licensing and collaboration agreement with China’s Kelun Biotech that will give it
rights to seven early-stage antibody-drug conjugate candidates against oncology targets. Merck paid a relatively small sum
of US$ 175 million upfront to Kelun as
part of the deal.After partnering with Sanofi for seven years, Regeneron Pharmaceuticals
acquired the global rights to cancer drug Libtayo from the French
drugmaker for an upfront payment of US$ 900 million. Regeneron paid another US$ 100 million to Sanofi after FDA
approved the drug as a first-line treatment for adult patients with advanced
NSCLC (to be administered in combination with platinum-based chemotherapy). As
part of the deal, Sanofi will receive a royalty of 11 percent on worldwide net
sales of Libtayo and will get another potential US$ 100 million in
sales-related milestone payments over the next two years.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Biocon acquires Viatris’ biosim business; Biogen sells stake in Samsung Bioepis Biocon Biologics, a subsidiary of Indian drugmaker Biocon, acquired US-based Viatris’ biosimilars business for US$ 3.34 billion. The deal expanded Biocon’s biosimilar portfolio of 20 treatments – including 11 that were with Viatris – by adding therapies for treating diabetes, tumors and autoimmune diseases. According to Biocon, Viatris’ biosimilar portfolio is expected to generate over US$ 1 billion in 2023.Samsung Biologics shelled out US$ 2.3 billion to take over partner
Biogen’s stake in Samsung Bioepis, which the duo had
set up in 2012 to develop and manufacture biosimilars. Biogen, however,
retained the commercial rights to both Byooviz (a biosimilar of Novartis’ eye drug Lucentis) and the investigational candidate SB15 (a biosimilar of Regeneron’s Eylea) along with the
biosimilars of Enbrel, Humira and Remicade.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Our viewGlobally, M&As slowed down substantially across all industries in 2022 as companies confronted challenges such as rising interest rates, a pullback in leveraged finance, bond-market jitters and the possibility of a recession. According to Refinitiv, the total value of deals announced globally fell 37 percent last year — the biggest year-over-year percentage drop since 2001.Going by these statistics, the pharmaceutical industry didn’t fare badly. In its latest ‘Pharmaceutical & life sciences: US Deals 2023 outlook’ report, PricewaterhouseCoopers has predicted a more active 2023, with “M&As to more closely resemble prior years” with a total deal value in the US$ 225 billion to US$ 275 billion range across all sub-sectors.The new year has begun on a
positive note, with three M&A deals worth over US$ 4 billion being announced at last month’s JP Morgan Healthcare Conference. A series of patent expirations are going to put global
prescription sales at risk through 2026. Therefore, it seems plausible that the recent momentum in M&A activities will continue throughout 2023.
Impressions: 3867
This week, AbbVie’s Humira (adalimumab) saw its 20-year exclusive
run come to an end in the United States as Amgen launched its copycat — Amjevita. This is just the start of
the onslaught of Humira copycats, as seven other biosimilars are due to be
launched this year.In a press statement, Amgen said
Amjevita (40 mg) is available in the US at a list price (wholesale acquisition
cost) 55 percent below the current Humira list price. According to a Reuters report, Humira’s US list price is US$ 6,922 per month. The biosimilar is also available at a list price 5 percent below the current Humira list price.“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said.Blockbuster that’s brought in US$ 200 billion so farHumira had bagged the US Food and Drug Administration’s approval in 2002. Back in those days, it was a part of Abbott. The drug had been developed
by a division of BASF Pharma, known as Knoll
Pharmaceuticals. Abbott had acquired Humira through its purchase
of Knoll in March 2001. In 2013, Abbott completed the separation of its research-based drugs business into an independent biopharmaceutical company — AbbVie.Humira is a tumor necrosis factor (TNF) blocker indicated for inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. From 2012 to 2020, Humira was
the world’s top selling drug. In 2012, it ousted Pfizer’s cholesterol drug Lipitor from the number one
spot. AbbVie reported Humira revenues of US$ 19.2 billion in 2019 and US$ 19.8 billion
in 2020. The drug brought in US$ 2.7 billion for AbbVie in 2021. However, that year, it lost its top-selling drug status to Pfizer’s Covid-19 vaccine Comirnaty.Since its approval in December 2002, Humira has brought in over
US$ 200 billion for AbbVie. Last year alone, the drug had delivered sales of US$ 15.6 billion until September 30, accounting for approximately 36 percent of AbbVie’s total net revenues. It is still a top-seller among non-Covid drugs.Humira’s controversial patent thicketThe original patent that covers Humira expired in 2016. Post that, FDA approved eight biosimilars for Humira. These are Amgen’s Amjevita (approved in 2016), Boehringer Ingelheim’s Cyltezo (2017), Sandoz’s Hyrimoz (2018), Samsung Bioepis’ Hadlima (2019), Pfizer’s Abrilada (2019), Viatris’ (earlier Mylan) Hulio (2020),
Coherus BioSciences’ Yusimry (2021) and Fresenius Kabi USA’s Idacio (2022).At present, Cyltezo is the only FDA-approved interchangeable biosimilar, giving it an edge over others since it can be substituted for Humira without a doctor's advice. However, this advantage may be short-lived. FDA is reviewing applications for interchangeability of Abrilada, Pfizer's approved product, and AVT02, Alvotech’s biosimilar under review. FDA is
expected to announce its decision on AVT02 in April.Even though Amjevita was approved in 2016, it wasn’t launched in the US as AbbVie used a strategy known as a “patent thicket” wherein the company applies for multiple patents in addition to the original one. Post that, AbbVie faced class action and
antitrust lawsuits from grocery workers’ union and welfare-benefit plans. In 2019, welfare-benefit plans that pay for Humira sued AbbVie in Chicago federal court, alleging its patent collection created an illegal monopoly by scaring off potential competitors.In June last year, a bipartisan group of US senators asked the US
Patent and Trademark Office to look into curbing the patent thicket. However,
in September, a US appeals court ruled that AbbVie’s use of a patent thicket did not unlawfully block competition. Humira’s last patent will expire in 2037.Our viewPost the launch of Amjevita, several
analysts have talked about how cost savings due to the launch of biosimilars
are expected to be limited given the complicated system of insurance, middle
men and rebates in the US.According to a March 2021 report brought out by the National Bureau of Economic Research, “competitive forces yield important price reductions as the number of competitors increase.”With each biosimilar entry, weighted average price ratios can fall anywhere between four and 10 percentage points, the report adds. Often,
the originator drops its price. In Europe, AbbVie had offered up to 80 percent discounts in November 2018, a month after Humira went off patent. It will be interesting to see how AbbVie counters the onslaught of biosimilars in the US.
Impressions: 1589
We usher in 2023 with the key highlights of the US Food and Drug Administration’s December 2022 list of Off-Patent, Off-Exclusivity (OPOE) Drugs with No Approved Generics. With this list, the FDA hopes to bolster competitiveness
in the generics market.The OPOE list gets updated every six months. Such updates are a part of FDA’s initiative to improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since 2017, the FDA has been publishing the OPOE list of drugs without an approved generic. For a year now, the FDA has been publishing two versions of the OPOE list — one for prescription drug products and one for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)Four
new applications added to Dec 2022 list; 96 first generics approved last yearWhile the FDA’s June 2022 list of OPOE Drugs with No Approved Generics had 98 new applications for prescription drugs, the December 2022 list saw a sharp decline — only four new applications were added during this period. We had witnessed a similar trend in 2021 — the December 2021 list had only 16 new applications as
opposed to 35 new applications in the June 2021 list.The four new applications were for diclofenamide (a drug to treat glaucoma), ephedrine sulfate (a drug used to treat asthma and
heart failure that also acts as a central nervous system stimulant), meloxicam (an arthritis drug) and pemetrexed (a chemotherapy medication). In
May 2022, the FDA approved the first generics for pemetrexed injection
developed by several companies, including Accord Healthcare, Fresenius Kabi, Apotex, Qilu Pharmaceutical, Biocon, Dr. Reddy’s Laboratories and
Zydus, to treat non-small cell lung cancer (NSCLC) and mesothelioma. Almost one-third of the prescription products – 184 out of 505 – are drug products delivered as injectables, and 68 entries are for oral solid dosage forms (such as tablets, capsules and modified release forms).In the June 2022 list, a total of 60 OTC
drug products were listed. This time too, the same number of OTC drug products
figured in the OPOE list. These include antiseptic agent chlorhexidine gluconate,
non-steroidal anti-inflammatory drug ibuprofen, anti-allergy drug loratadine and painkiller acetaminophen. Of these, 19 are delivered as
oral solid dosage forms (such as
tablets, capsules and modified release forms).In 2022, the FDA approved 96 first generics. This is slightly higher than
the 93 approved by the agency in 2021.As the name suggests, “first generics” are the first approvals handed by the FDA to manufacturers to market a generic product in the United States. The agency considers first generics to be important to public health, and prioritizes review of these submissions.View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)AbbVie’s Humira, Novartis’ Entresto to finally face generic competitionAbbVie is facing one of the steepest patent cliffs in the industry’s history, with Humira slated to face the onslaught
of eight biosimilars this year. The blockbuster drug had generated US$ 21.2 billion in 2021. Amgen’s Humira biosimilar – Amjevita – will hit the market this month. The other Humira
biosimilars that will be launched this year include Abrilada (Pfizer), Cyltezo (Boehringer), Hadlima (Samsung Bioepis), Hyrimoz (Sandoz), Hulio (Viatris) and Yusimry (Coherus BioSciences). In mid-December, Fresenius Kabi became the latest
company to win US approval for its Humira copycat — Idacio.Novartis’ heart failure drug Entresto will also go off patent this month. The blockbuster drug had generated US$ 3.5 billion in 2021.View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)Our viewIn our previous OPOE drug listing, we had talked about FDA’s intent to bring down drug prices, with the agency putting 98 new applications of prescription drugs in the OPOE list for June 2022. That intent has only become stronger with the US Patent and Trademark Office (USPTO) and the FDA joining hands to promote
competition. The two bodies are working towards improving the patent system in an effort to stop its misuse through “patent thickets”, “evergreening” and “product-hopping”. With this clear intent to lower drug prices in the US, the OPOE lists for 2023 and beyond are likely to get more interesting. For now, all eyes are set on what generic competition will do to blockbusters like AbbVie’s Humira and Novartis’ Entresto.
Impressions: 2761
Every year, the list of top pharmaceutical products and companies by sales sees some churn. But the year 2021 was a lot different — it saw the pharma industry landscape change dramatically. It was a
year when the industry was busy developing vaccines and therapies so that the
world could recover from the Covid-19 pandemic. And this resulted in many
drugmakers raking in billions of dollars in sales.
As a result,
the top company of 2020 in terms
of pharmaceutical sales — Roche — slipped to the number five spot, while Pfizer, which was at number eight in 2020 after
spinning off its generic business, moved up to the number one slot.
The year
proved to be a good one for pharmaceutical companies.
Interestingly, last year none of the top 20 pharmaceutical companies saw a decline in
their revenue.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Pfizer’s Comirnaty steals the show
The
company that reaped the maximum gains from its Covid vaccine was Pfizer.
Comirnaty (tozinameran) was the top selling pharmaceutical
product of 2021, posting global revenues of US$ 36.8 billion. This
messenger-RNA Covid-19 vaccine, developed along with its German partner BioNTech, catapulted Pfizer to the slot of the top company by sales in 2021. Pfizer’s global topline grew from US$ 41.7 billion in 2020 to US$ 81.3 billion in 2021.
In
2020, Pfizer was at
number eight, behind Roche, Novartis, GSK, AbbVie, J&J, Merck and BMS. In 2021, it took a lead of billions of dollars on all these companies. The second largest drug company by sales — AbbVie — was way down at US$ 56.1 billion in global revenues. In fact, Comirnaty has
become the fastest-selling drug in the history of the pharmaceutical
industry.
Back in
December 2020, when both Comirnaty and Moderna’s Spikevax had bagged the US Food and Drug Administration’s emergency use authorization (EUA), there was a lot of uncertainty around how the promised doses would be delivered across the world. But both Comirnaty and Spikevax have proven to be a resounding success. Spikevax emerged as the third largest selling pharmaceutical product of 2021, bringing in US$ 17.7 billion for Moderna.
Analysts
expect both Pfizer-BioNTech and Moderna to sell even more vaccines in
2022. The reasons are manifold. First, SARS-CoV-2 is able to mutate often, and
is unlikely to be eradicated in the near future, creating a need for booster
shots. Second, the younger age groups are still to get vaccinated.
Along with
Comirnaty, Pfizer is battling Covid-19 with its antiviral pill, Paxlovid. Though the sales of Paxlovid have nosedived of late, Pfizer expects
Comirnaty and Paxlovid to help the New York-headquartered drug behemoth achieve US$ 100 billion
in 2022 revenues.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
AbbVie
moves up, sans Covid product; Roche slips to number five
With no
Covid-19 related products, AbbVie did fairly well in 2021 — it moved up from the number four spot in 2020 to number two position, thanks to its Allergan acquisition, cash cow Humira (adalimumab), the continued success of its
cancer drug Imbruvica (ibrutinib) and an increase in sale of its psoriasis treatment Skyrizi (risankizumab) by a whopping 85 percent in 2021. Humira brought in sales of US$ 21.2 billion for AbbVie in 2021. However, things may change soon, with biosimilars of Humira slated to enter the market in 2023. The years 2022 and 2023 are likely to be transition years for AbbVie, as it works to build the market for its Humira successors — Rinvoq and Skyrizi.
Roche
emerged as a big loser in 2021, as several copycats of its blockbuster drugs
hit the market. Copycats to Roche’s three blockbuster cancer drugs—Avastin, Herceptin and Rituxan—eroded US$ 4.9 billion (CHF 4.73 billion) from the company’s sales in 2021. A large chunk
of growth for Roche came from its multiple sclerosis med Ocrevus, hemophilia drug Hemlibra, inflammatory disease therapy Actemra and PD-L1 inhibitor Tecentriq. The pandemic resulted in
lower-than-expected sales of Ocrevus (ocrelizumab) due to fears around its
immunosuppressive effects.
Like Roche, Novartis also slipped last year. It fell from
number two in 2020 to the number four slot in 2021. Essentially, Novartis is
struggling with a relatively lackluster pipeline. It had sold its 33 percent stake in Roche last
year for US$ 20.7 billion. It plans to use that sum for acquisitions in order
to beef up its pipeline. The Swiss drugmaker has also drawn up a restructuring
plan that includes layoffs of thousands of employees.
Before the
pandemic, Merck’s Keytruda was touted as the drug that would overtake
Humira at the top in 2024. The checkpoint inhibitor has continued to grow
impressively, adding new indications and treatment lines. Keytruda is now used
in close to 40 indications. With US$ 17.2 billion in sales, Keytruda emerged as
the fourth largest selling drug of 2022.
Overall
though, Merck slipped from number six to the number eight slot. This was due to
the fact that Merck had spun out its women’s
health, biosimilars and established brands businesses into Organon. However, its Covid-19 antiviral pill — Molnupiravir — was able to compensate for the lost revenue. Though the FDA is yet to grant the drug a full approval (it bagged an EUA in December 2021), advance sales agreements helped it rack up US$ 952 million in sales in the fourth quarter.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
BMS moves
up with Eliquis, Revlimid; J&J lands at number three
Bristol Myers Squibb (BMS) moved up from number seven in 2020 to number six, thanks to two of its drugs that made it to top 10 — anticoagulant Eliquis at number five and oncology drug Revlimid at number six. However, Revlimid will soon face competition — four generic companies now have the approval to sell their versions of Revlimid (lenalidomide) after March 2022. Revlimid
sales are expected to drop from US$ 12.9 billion to just US$ 2.06 billion in
2026.
BMS posted
US$ 46.4 billion in global revenues, a nine percent increase from US$ 42.5
billion reported in 2020. In immuno-oncology, Opdivo
brought in US$ 7.52
billion in sales, while Yervoy drew in sales of US$ 2 billion
(an increase of 20 percent).
J&J’s pharma division brought in US$ 52.1 billion in revenues
last year, an increase of 14 percent over its revenues of US$ 45.6 billion
posted in 2020. Drugs like Darzalex (for multiple myeloma), Stelara and its Covid-19 vaccine brought in growth during 2021,
helping J&J move up from number five to the number three slot. J&J’s Covid-19 vaccine brought in US$ 2.4 billion in
sales.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
GSK bags
approval for shingles vaccine; Takeda suffers setbacks
GlaxoSmithKline (GSK) slipped four places — from number three in 2020 to number seven in 2021. Though GSK did not have a drug in the top 10, sales of GSK and Vir Biotechnology’s Covid-19 antibody treatment
sotrovimab helped produce a seven percent increase in its 2021 revenue. The British drugmaker also bagged a critical FDA approval — its vaccine to prevent shingles (herpes zoster), Shingrix, bagged the agency’s nod in July. GSK hopes to double the sales of Shingrix by 2026.
GSK is also undergoing a major transformation, and plans to demerge its consumer health unit this year. The unit generated revenues of £9.6 billion (US$ 13 billion) last year, and GSK sees the demerger as a necessary step to fuel growth through the development of new vaccines and specialty medicines.
Sanofi managed to retain its ninth slot, even as
its global turnover increased from US$ 39.3 billion (Euro 36.04 billion) to US$
41.6 billion (Euro 37.76 billion). It snapped up Kymab, Tidal Therapeutics, Translate Bio, Kadmon Holdings, Origimm Biotechnology and Amunix in deals that bolstered its presence in immunology, immuno-oncology and vaccines. Dealmaking is on the French drugmaker’s menu for 2022 and beyond, Sanofi’s CFO said at this year’s virtual JP Morgan Healthcare Conference.
AstraZeneca’s global revenues grew from US$ 26.6 billion in 2020 to US$ 37.4 billion in 2021. However, its rank fell from nine in 2020 to 10 in 2021.
AstraZeneca
wrapped up the US$ 39 billion acquisition of Alexion in July 2021. Alexion’s rare disease franchise—led by C5 inhibitors Soliris and Ultomiris—added an extra US$ 3.1 billion to Astra’s top line last year.
Takeda suffered several clinical and regulatory setbacks in 2021, which it labeled as an “inflection year.” For Gilead, sales of its Covid-19 antiviral Veklury brought in US$ 5.6 billion last year,
helping its revenues grow by 11 percent.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Our view
If anything,
the pandemic has taught us that change is the only constant. It has also taught
us that products can become blockbusters in a matter of a few months.
The industry
landscape continues to change. On the one hand, we are seeing people scrambling
to get Covid vaccines and booster shots, on the other hand, the FDA has limited the use of monoclonal antibodies, such as Eli Lilly’s bamlanivimab and etesevimab and
Regeneron’s REGEN-COV (casirivimab and
imdevimab), in treating Covid caused by the Omicron variant. The FDA has also pulled the authorization
granted to GSK and Vir Biotechnology’s antibody therapy this month,
citing data that suggested it was unlikely to be effective against the dominant
Omicron sub-variant.
And last
week, there was news that demand for Pfizer’s
antiviral pill Paxlovid has remained unexpectedly low. The supply
of Paxlovid, which reduced hospitalizations or deaths in high-risk patients by
around 90 percent in a clinical trial, has far outstripped demand in many
countries like the US, the UK and South Korea.
Though Pfizer is hopeful of crossing US$ 100 billion in revenue this
year, much depends on how the pandemic pans out and what new research has to
say about the novel coronavirus. A lot will change once the pandemic becomes endemic.
The first four months of 2022 tell us that vaccines like Comirnaty and Spikevax
will continue to perform well.
But two years down the line, our charts could look very different.
Impressions: 8049
Nearly every
year, drugmakers ring in the new year with drug price increases in the US. This
year too, prices of over 450 prescription
medicines increased by an average of around 5 percent at the start of January.
This, when high drug prices have been one of the biggest political issues in
the US over the last few years.
PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Rising healthcare, drug spends in US
Over the
last several years, we have repeatedly heard political leaders in the US
complain about high drug prices. Yet, drug prices and healthcare spends have
risen unabated.
America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8
trillion, accounting for 17.7 percent of the gross domestic product (GDP).
During the year, prescription drug spend increased by 5.7
percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7
percent to US$ 799.4 billion.
President
Joe Biden recently stressed on the need to cap the prices of essential drugs,
and said that the average American pays the highest prices for prescription
drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.
Pharma
companies, on the other hand, have vehemently argued against any price cuts in
the US, saying price cuts would hinder drug research and development for all
diseases.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Patented drugs account for 80.3 percent of total Part D spend
Medicare is the US federal government’s program that
provides health insurance to most people who are 65 years
or older. Medicare’s Part D plan provides outpatient drug coverage through private
insurance companies that have contracts with the federal government. Eligible
people have to choose and enroll in a private prescription drug plan for Part D
coverage. Medicare Part B, on the other hand, covers a wide variety of
medically necessary outpatient services and some preventative services.
Prescription
drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending
on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent
of the total spend for the year. Generic drugs made up for the remaining 19.7
percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8
billion were sold under Part D, accounting for 21 percent of the total spend
under the program.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Eliquis ranks highest on Medicare’s brand drug spend
Under Part
D, endocrinology and oncology were the two therapeutic areas that generated
maximum revenue for pharma companies, driving home sales of over US$ 31.8
billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of
around US$ 22.9 billion.
Among branded
drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018.
Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up
by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each
under the program.
Amongst
generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with
electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the
overall dosage units sold also jumped higher by 2.25 billion units to 111.35
billion.
The sales
ranking of Part D does bare some similarities with the global ranking of
highest selling drugs. In 2020, Humira had retained its position as the highest
selling drug in the world, generating sales of US$ 20.4 billion. Both
Eliquis and Revlimid had retained their ranking as the third and fourth most
selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global
sales in 2020.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Medicare’s inability to negotiate prices costs American taxpayers billions of dollars
Over the
years, drug companies have used Medicare’s
inability to negotiate prices under Part D to increase the prices of their
drugs significantly and rip off huge profits, a three-year-long US House
Oversight Committee investigation has revealed.
US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between
2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.
Elsewhere in
the world, the same drugmakers are bending over backwards to get into medical
insurance programs. For instance, China reported that several international
pharma firms, many of them headquartered in the US, slashed the prices of their
drugs by up to 94 percent to get into the country’s national medical insurance coverage.
In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022
if an expensive Alzheimer’s drug, Aduhelm, is included in the list.
In order to
ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Our view
President
Biden's Build Back Better legislation,
which the House passed last month, is up for vote in the Senate. The
legislation contains provisions that would allow Medicare to negotiate the
prices of some expensive drugs, penalize drugmakers who raise prices faster
than inflation and cap out-of-pocket costs for insulin at US$ 35 per month.
However, chances of the bill being passed in its present form are slim.
Even if the
Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025.
The number would increase over the years, reaching 100 in six years, and hence
forth grow by 20 drugs a year.
It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Impressions: 2653
Last
year, the pandemic impacted everyone’s life in one way or the other. It turned
the limelight on to the pharmaceutical industry, which stepped up efforts to
deliver treatments and vaccines for Covid-19. It was a year of challenges for
the drug
industry as it struggled to supply existing drugs and treat emergencies
amid disruptions in the way business was conducted the world over.
Unlike previous years when the top five drug companies largely remained unchanged, 2020 saw several movers and shakers. The acquisition of Allergan by AbbVie helped it enter the ‘top five’ list, while companies like Pfizer and Merck got edged out. Despite a 2 percent increase in revenues, Pfizer dropping out
of the top five was not a complete surprise as it spun-off its
Upjohn unit. The unit merged with Mylan to create Viatris, an entity
with over US $10 billion in revenues.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Roche emerges as top drug company by global sales
The
top five list of global pharmaceutical companies by sales in
2020 was quite a mix of surprises. While Swiss major Roche topped the
ranking of global drug companies by pharmaceutical sales (with global revenues
of US$ 49.6 billion or CHF 44.532 billion), it also witnessed a sales decline
of 8 percent, which was partially an outcome of the Swiss franc gaining against
most currencies during the pandemic. Overall, competition from biosimilars and the Covid-19 pandemic had a negative impact on Roche’s
pharmaceutical sales in 2020. However, it witnessed strong sales growth
of newly launched medicines like Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla, which
helped in offsetting the CHF 5 billion (US$ 5.53 billion) impact of competition
from biosimilars.
At
the
second position was Swiss drugmaker Novartis, whose global sales (at US$ 48.7 billion) were marginally lower than Roche’s. Unlike the numero uno, Novartis’ pharmaceutical sales grew 4 percent, driven by cardiology drug Entresto that witnessed a 44 percent increase in revenues. While its
oncology unit and Sandoz’s biosimilars business also posted an increase in sales, Covid-19 negatively impacted demand, particularly for the company’s ophthalmology and dermatology operations and the retail operations of Sandoz. The year also saw Novartis’ gene therapy
Zolgensma, the world’s costliest drug, reach nearly US$ 1
billion in sales.
As
the British pound became a lot stronger against the US dollar, GlaxoSmithKline Plc (GSK) witnessed a 3 percent increase in sales in constant currency terms and saw its group sales (£ 34.1 billion or US$ 47.27 billion) take the number three spot in US dollar terms. Strong sales performances
from key growth drivers in HIV, respiratory, oncology and consumer healthcare
offset disruptions from Covid-19. GSK’s consumer healthcare division reported over £10 billion (US$ 13.91 billion) in sales and the firm is on track to create new standalone biopharma and consumer healthcare companies in 2022.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
AbbVie’s international Humira sales
drop 13.6% due to biosimilars
AbbVie reported worldwide revenues of US$ 45.8
billion, an increase of 38 percent versus the previous year. This included US$ 10.3
billion in revenues from the Allergan acquisition,
growth in the immunology portfolio, and the continued strength of Humira in the US as
well as revenue growth from Imbruvica and Venclexta. Humira, the
best-selling drug since 2012, continued to dominate with US$ 19.83 billion in
sales, an increase of 3.5 percent as compared to 2019. While the
international sales of Humira dropped 13.6 percent due to competition from biosimilars, in the US sales increased as Humira is protected from biosimilar competition until 2023.
J&J’s
pharmaceutical division delivered a strong performance as its pharmaceutical
sales grew 8 percent to US$ 45.6 billion and contributed more than the combined sales of its other two units — consumer health and medical devices. This sales growth was largely attributed to primary operational drivers including Imbruvica and Stelara, which were
among the top 10 drugs by sales in 2020. J&J and AbbVie have an equal share
in the profits (and losses) from the sales of Imbruvica, which witnessed a
double digit increase in sales to US$ 9.4 billion. Similarly, J&J’s Stelara
reached US$ 8.0 billion in sales. J&J’s overall revenues grew by just 0.6 percent
to US$ 82.6 billion (including sales from its consumer health and medical
devices divisions). It will be interesting to see what J&J’s 2021
revenues look like as it benefits from the sales of its single-dose Covid-19
vaccine.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Merck’s Keytruda on its way to becoming world’s best-seller
With AbbVie’s Humira beginning to face generic competition, Merck’s oncology
drug Keytruda continued to go from strength to strength posting a sales growth of 30
percent. Keytruda delivered more than US$ 14.4 billion in sales, almost a third
of the firm’s US$ 43 billion revenue. It’s only a matter of time before Keytruda becomes the world’s best-selling drug.
Bristol Myers Squibb (BMS)
reported worldwide revenues of US$ 42.5
billion in 2020. BMS’ products Revlimid and Eliquis reported
significant growth last year, and followed Humira and Keytruda in terms of sales. Eliquis, which is also promoted by Pfizer in some geographies,
had total sales of US$ 14.1 billion while Revlimid posted over US$ 12 billion
in sales. Revlimid, which BMS picked up through its acquisition
of Celgene, will face
limited generic competition sometime after March 2022. Furthermore, while BMS’ oncology
treatment Opdivo’s sales (US$
7.2 billion) declined by 3 percent compared to 2019, it remained one of the top selling drugs in 2020 (US$
7.9 billion) with a small portion of sales coming from Ono Pharma in Japan.
Sanofi reported
approximately US$ 43.6 billion (€36 billion) in net sales
for 2020, which rose by 3.3 percent at constant exchange rates even as some of
its flagship products’ sales declined due to generic and
biosimilar competition. Solid performances from Dupixent, vaccines and its
specialty care global business unit across all geographies, more than offset
lower sales.
In
the case of Gilead, while
products like Biktarvy in its HIV
portfolio witnessed a growth of over 50 percent to more than US$ 6 billion,
it was Gilead’s treatment for Covid-19 — remdesivir — promoted under the brand Veklury which went from no sales in 2019 to US$ 2.81 billion in sales in 2020.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Our view
The
human health business of many companies was negatively impacted by the Covid-19
pandemic. However, operating expenses saw a reduction due to lower promotional
and selling costs, as well as lower R&D expenses.
This
year, as Covid vaccines from Pfizer, Moderna, J&J and AstraZeneca are rolled out in more
countries across the world, they are expected to ring in significant
revenue contributions for these companies. For instance, Pfizer recently announced
that it expects US$ 26 billion in revenues from the sale of its vaccine
in 2021. Similarly, Moderna said it expects US$ 19.2 billion in sales from its Covid-19 vaccine this
year.
Given this scenario, the order of the top drug companies and the sales contribution of various drugs will change significantly in 2021. It seems likely that Pfizer’s vaccine will become the best-selling product by sales in 2021 and the American drugmaker will be back among the top five in the global drug companies by sales list.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Impressions: 13327