Nine More Years? Sandoz Loses Again On Enbrel Biosimilar

Sandoz Has Held FDA Approval For Its Erelzi Version Since 2016

Sandoz has failed to overturn on appeal an invalidity ruling for two patents covering Enbrel in the US, barring a path to market for its Erelzi biosimilar, potentially until patent expiry in 2029.

2029_Ice
Sandoz' biosimilar etanercept launch plans may be on ice until 2029 • Source: Shutterstock

Biosimilar competition in the US to Amgen’s Enbrel (etanercept), the $5bn autoimmune diseases treatment, is at risk of not materializing for nine more years after a US Court of Appeals upheld the validity of two patents covering the drug, at the expense of etanercept biosimilar sponsor Sandoz.

Following the decision, Sandoz said it was “evaluating its options,” including a potential appeal to the US Supreme Court. Carol...

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