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

Coherus’ Ranibizumab Date And Key Biocon Biosimilar Inspections Feature

 
• By Dean Rudge

A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.

What's Next Image
August looks set to be another busy month • Source: Citeline

Biocon could be set to achieve long-awaited US Food and Drug Administration approvals for the company and partner Viatris’ proposed biosimilars to Avastin (bevacizumab) and NovoLog (insulin aspart) in due course, with the Indian biotech awaiting key FDA site inspections in August to get the products over regulatory line.

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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.

Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
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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.