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Sandoz Will Appeal Against US Enbrel Patent Setback

 
• By Aidan Fry

Sandoz expects to bring an expedited appeal against a US district court’s finding that two patents protecting Amgen’s Enbrel etanercept brand until 2028 and 2029 are valid. 

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Sandoz could be barred from launching its Erelzi biosimilar etanercept in the US until 2029 following an adverse district court ruling • Source: Shutterstock

Sandoz says it will appeal against a New Jersey district court’s long-awaited patent ruling that threatens to deter US market entry for its Erelzi (etanercept-szzs) biosimilar of Amgen’s Enbrel original for another decade. Sandoz has held approval for Erelzi for the past three years, but has been unable to launch due to an injunction linked to the litigation over two US patents that do not expire until 2028 and 2029. The parties have agreed to expedited appeal proceedings.

With the US Food and Drug Administration having first approved Enbrel in November 1998, Amgen stands to enjoy more than...

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