DKSH

DKSH India Earns Great Place To Work Certification for the 2nd Time

09 Sep 2024

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DKSH Extends Cosucra Distribution Agreement In Australia And NZ

14 Aug 2024

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DKSH and Kyowa Kirin Forge Strategic Partnership Across Asia-Pacific

02 Aug 2024

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DATA COMPILATION
#PharmaFlow

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Fi Europe 2024

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DIGITAL CONTENT

6 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 178 NEWS #PharmaBuzz

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6 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
178 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

100 All APIs, 100 Listed APIs

100 All APIs
100 Listed APIs

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

12 All Intermediates

12 All Intermediates

EXCIPIENTS

47 Listed Products

excipientPortfolio
47 Listed Products

EXCIPIENTS BY INGREDIENTS

Hydroxypropyl Cellulose, Glyceryl Tricaprylate Excipient, Gelatin Excipient, Carrageenan, Hydroxyethyl Cellulose Excipient, Titanium Dioxide, Xanthan Gum, Dextran 40 Excipient, Gamma Cyclodextrin Excipient, Calcium Carbonate Excipient, Yellow Ferric Oxide S, Saccharinum, Dextran 5 Excipient, Cocoa, Hydrogenated Soybean Oil, Sodium Carboxymethyl Cellulose Excipient, Beta Cyclodextrin, Dextran 70 Excipient, Calcium Sulfate Dihydrate Excipient, Sodium Saccharin Excipient, Hydrogenated Cottonseed Oil Excipient, Boric Acid Excipient, Silicon Dioxide, Triethanolamine Excipient, Red Ferric Oxide S, Glyceryl Monocaprylate Excipient, Dextrin Excipient, Petroleum Jelly Excipient

EXCIPIENTS BY APPLICATIONS

Fillers, Diluents & Binders, Thickeners and Stabilizers, Topical, Rheology Modifiers, Solubilizers, Lubricants & Glidants, Coloring Agents, Parenteral, Taste Masking, Coating Systems & Additives, Emulsifying Agents, Surfactant & Foaming Agents

excipientsByApplications
Fillers, Diluents & Binders
Thickeners and Stabilizers
Topical
Rheology Modifiers
Solubilizers
Lubricants & Glidants
Coloring Agents
Parenteral
Taste Masking
Coating Systems & Additives
Emulsifying Agents
Surfactant & Foaming Agents

INSPECTIONS & REGISTRATIONS

3 FDA

inspections
3 FDA

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

About

DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering growth for businesses in Asia and beyond for over 155 years. DKSH operates in 36 markets, is listed on the SIX Swiss Exchange, employs 33,100 specialists, and generated net sales of CHF 11.1 billion in 2021. It is the leading global distributor of innovative pharma ingredients for pharmaceutical synthesis and formulation. It offers a range of products, ranging from animal care products to packaging materials, intermediates to nutraceuticals, and APIs to excipients.

CPhI India 2024CPhI India 2024

Industry Trade Show

Booth #8.R08

26-28 November, 2024

India Expo Centre, Greater Noida
Fi Europe 2024Fi Europe 2024

Industry Trade Show

Exhibiting

19-21 November, 2024

Frankfurt, Germany
Chinacoat 2024Chinacoat 2024

Industry Trade Show

Exhibiting

03-05 December, 2024

China Import and Export Fair Complex

CONTACT DETAILS

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Switzerland

Address

Wiesenstrasse 8, P.O. Box 888 Zurich, Zurich 8034, CH

Telephone

+49 4037473411

himali.pawaskar@dksh.com

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https://www.dkshdiscover.com/pim/en/

https://www.linkedin.com/company/dksh

YouTube

http://www.youtube.com/@DkshGroup

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CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

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Performance Materials Brochure 2024

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Corporate Video

Cosmetics Total Solutions

Performance Materials

DATA COMPILATION #PharmaFlow

FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

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.