Market Place
This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity
Drugs without an Approved Generic (OPOE list). The list is a crucial
resource for promoting competition and affordability in the pharmaceutical
industry. Updated biannually in December and June, the OPOE list serves as a
transparent guide for drug manufacturers.
Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs).
ANDAs are a streamlined pathway for generic drug development,
offering a more cost-effective alternative to brand-name drugs. By highlighting
drugs that lack generic competition on the OPOE list, FDA aims to incentivize
manufacturers to develop generics, ultimately leading to greater affordability
and access for patients.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
ALS drugs, cancer, asthma,
HIV treatments among new drugs added to OPOE list
The December 2023 OPOE list had 23 new applications of branded
drugs eligible for but without generic competition. The June list further added
21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic
lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in
patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and
bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).
Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms).
The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat.
The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller
This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and
others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product.
The agency considers first generics to be important to public
health and prioritizes review of these submissions. First generics are eligible
for a 180-day exclusivity period.
Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat
thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal
chromosome in their blood cells called the Philadelphia chromosome), got its
first generic in January, which was introduced by Apotex. Tasigna brought
in sales of US$ 1.85 billion in 2023 and its sales are
projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients
with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in
April.
Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved
drug to treat tardive dyskinesia, a disorder that involves involuntary
movements. It raked in US$ 1.84 billion in 2023, registering a
year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
Our view
The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or
a democrat takes over the US administration, making medicines affordable should
remain a priority.
In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.
Impressions: 2494
https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments
#PharmaFlow by PHARMACOMPASS
11 Jul 2024
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This week, Phispers brings you contrasting news on two immunotherapy drugs -- Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda. In other news, Bangladesh begins exporting drugs to the US, while Myanmar struggles to curb a crystal meth boom. And Sanofi’s acquisition of Boehringer Ingelheim’s consumer health business gets a conditional approval from the European Commission.
Bristol-Myers Squibb reanalyzes cancer
drug, as Merck races ahead with Keytruda
First approved
in 2014, Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo – also known as checkpoint inhibitors – have been forecast to be among the top 20 best-selling
drugs in the world by 2020. They represent the hot new field of immunotherapy
and are known to have given 90-year old Jimmy Carter (former President of the
United States) hope in his fight against cancer.
However, the field
of immunotherapy received a nasty surprise when Bristol-Myers Squibb said its
treatment Opdivo had not slowed the progress of advanced lung cancer in a trial
which compared it with conventional chemotherapy.
While Bristol-Myers’ stock price plunged, Merck announced that not only did Keytruda succeed in a clinical trial as an initial
treatment for advanced non-small cell lung cancer, but patients actually lived
longer. In addition, the FDA approved Keytruda for head-and-neck cancer.
Bristol-Myers Squibb is re-analyzing the (patient groups’) data in a trial called CHECKMATE-026 to see whether it can salvage the study.
China’s FDA proposes new drug registration rules
China Food and
Drug Administration (CFDA) has issued new proposals to revamp China's Drug Registration Rules (DRR).
The proposals offer the prospect of eliminating a backlog of drug reviews, updating
China's drug classification system and reforming clinical trial rules to allow
parallel drug development in and outside of China.
The modified
rules would also eliminate statutory timelines for CFDA to review applications
and prohibit sponsors from marketing APIs without an approved drug product
marketing application.
Analysts say
the new regulations could weaken intellectual property protection in China and
effectively force API manufacturers to seek marketing approval of drugs. In the
long term, the new regulations may even reduce the number of API manufacturers
in the country.
Indian drug regulator eases norms for
clinical trials
The Drugs
Controller General of India (DCGI), in a recent notification, eased norms related to pharmaceutical research in
India, paving the way for an increase in the number of clinical trials being
run in the country.
Under the new
ruling, an investigator or researcher can now undertake as many trials as
approved by the ethics committee, as opposed to the present cap of three
trials. The regulator has also relaxed norms for hospitals or clinical sites
undertaking such trials. Through a separate notification, the DCGI has revised
the rule that prohibited any hospital with less than 50 beds to take up a
trial.
This announcement comes at a time when foreign drug regulators such as the US Food and Drug Administration (FDA) and EU's European Medicines Agency (EMA) have increased their inspections of Indian clinical research organizations (CROs). Incidentally, India’s share in global clinical trials today is only 1.46
per cent.
India’s pharma sector behind Myanmar’s crystal meth boom
Cold pills
contain pseudoephedrine, the main ingredient of meth, which is a highly addictive drug whose ever-soaring popularity is rattling governments across Asia. Meth is sold in pill form, known as ‘ya ba’ (Thai for ‘crazy medicine’), or in a more potent, crystalized form, known as ‘crystal meth’, ‘ice’ or ‘shabu’.
Myanmar's current boom in meth production would not have been
possible without a recent surge in smuggling of pseudoephedrine from across
India's huge and ill-regulated pharmaceuticals sector.
In a raid held in Myanmar in mid-June
, the police intercepted a car carrying more than 60 kg (130 lbs) of Indian pseudoephedrine – enough to make more than a million ‘ya ba’ pills.
According to the US State Department 2015 report, global demand for methamphetamine has created “new precursor chemical entrepreneurs in India”.
Myanmar police
say China is also a major supplier of pseudoephedrine. But with tighter
controls there, and with greater demand for the chemical as meth use booms,
drug producers have increasingly turned to India.
Bangladesh’s Beximco is the first company to export drugs to the US
The first pharmaceutical product made in Bangladesh has hit the American market, opening a new window for increasing the country’s export earnings. The company is Beximco Pharmaceuticals, and the product it will export is Carvedilol – a hypertensive drug.
The United States is the largest and most lucrative pharmaceutical market in the world. It is also one of the most regulated markets in the world. While congratulating Beximco, Bangladesh’s health minister Mohammed Nasim said “receiving the FDA nod is a rigorous process”.
European Commission clears Sanofi-Boehringer Ingelheim deal
The European Commission approved the (proposed) acquisition
of the consumer health business of Boehringer
Ingelheim by Sanofi, subject to conditions.
Under the approval, France’s Sanofi and Germany’s Boehringer
Ingelheim have to divest a number of businesses in the Czech Republic,
Estonia, France, Hungary, Greece, Ireland, Latvia, Poland and Slovakia.
The Commission had concerns that the transaction would have
reduced competition in some pharmaceutical products in these markets where both
the companies have very strong products, with a lack of alternatives. This,
according to the Commission, could have led to higher prices and less choice
for customers.
The commitments offered by Sanofi address these concerns. Sanofi
offered to divest either its own or Boehringer Ingelheim's local businesses in
the markets concerned, including the relevant marketing authorizations,
customer information and brands, and personnel.
This news comes at the time when Mylan has
wrapped up its US
$ 7.2 billion acquisition of Meda,
which will now operate as a controlled subsidiary of Mylan.
Six executives of Novartis’ Korea unit indicted in doctor bribery case
The Korean unit of Novartis has come under fire for bribing doctors for prescribing the company’s medicines. Six former and current Novartis executives at its Korean unit allegedly paid more than US $ 2 million to doctors in return for prescribing its medicines. Among those indicted was the former chief executive of Novartis’ Korea unit.
Moreover, six
publishers of medical publications and 15 doctors who work at general hospitals
were also indicted. Novartis funded academic events that were supposedly
organized by these publications. According to Korea Herald, these publications distributed money to doctors, disguised
as attendance fees and as fee for articles that the doctors contributed to the
publications.
These activities occurred between 2011 and 2016. Six months ago, the Seoul Western District Prosecutors’ Office raided Novartis’ offices in search of evidence that the drug maker had paid bribes.
Impressions: 3936
https://www.pharmacompass.com/radio-compass-blog/china-proposes-new-drug-registration-rules-india-eases-norms-for-clinical-trials
#PharmaFlow by PHARMACOMPASS
11 Aug 2016
