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Pfizer Warns Against Applying Generic Policies To Biosimilars

Global Biosimilars Commercial Lead Roman Irsiegler Talks Market Sustainability

 
• By Dave Wallace

Pfizer’s biosimilars commercial lead, Roman Irsiegler, has set out his views on policy obstacles for biosimilars that need to be addressed if the market is to sustainably deliver on its potential.

NEW YORK CITY - MAY 2015: Metal plate logo of Pfizer in his headquarters building. Pfizer is an American multinational pharmaceutical corporation, one of the world's largest pharmaceutical companies.
Pfizer has spoken out on biosimilar policy priorities

Pfizer remains one of the world’s leading biosimilars players, boasting a portfolio that covers multiple molecules and treatment areas, and which enabled it to rack up more than $2bn in biosimilars sales in both 2021 and 2022.

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Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

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BGMA Becomes Medicines UK

 
• By Dave Wallace

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J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

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J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By Dean Rudge

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
• By Dean Rudge

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.