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.
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Sandoz is seeking an en banc rehearing of a recent appeals court decision that stands to keep its Erelzi biosimilar etanercept rival to Enbrel off the market until 2029 in the US, claiming that the ruling provides a “playbook” for originators to extend patents beyond their legitimate terms.
Amgen’s biosimilar revenues were more than $350m in the second quarter of this year, as the company benefitted from the ‘innovator product’ commercialization model across its increasingly broad portfolio of biosimilars.
Having benefited financially from the increased demand from the coronavirus pandemic in the first quarter, Sandoz saw a reversal of fortune in Q2 as sales fell by more than one-tenth as reported, as the company explained to Generics Bulletin.