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Amgen Tells Sandoz On Enbrel: You Lost On The Facts

Sandoz Has Taken Etanercept Biosimilar Fight To US Supreme Court

 
• By Dean Rudge

Amgen has hit back at Sandoz’ petition for a writ of certiorari against a US Court of Appeals for the Federal Circuit decision that leaves the biosimilar sponsor unable to market its Enbrel biosimilar more than three decades after the biologic was first launched.

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Amgen has responded to Sandoz' 29 January petition • Source: Shutterstock

Amgen has told the US Supreme Court there is “no error to correct,” following Sandoz’ petition for certiorari review of an unfavorable US Court of Appeals for the Federal Circuit decision which blocked the biosimilar sponsor’s path for a rival to the originator’s Enbrel (etanercept) $5bn autoimmune diseases treatment.

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Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• 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

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• By Dean Rudge

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