Amgen Tells Sandoz On Enbrel: You Lost On The Facts
Sandoz Has Taken Etanercept Biosimilar Fight To US Supreme Court
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’s management took a deep dive into biosimilar market dynamics during the company’s third-quarter earnings call, as the California-based biotech continued to enjoy success for biosimilars in the US and Europe.
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.
Going toe-to-toe with Amgen on its Neulasta Onpro on-body injector device is a key strategic goal for Coherus BioSciences, although news will be kept concealed until the company’s proposed biosimilar is approved or launched.