Fed. Circ. Clears Amgen's Avastin Biosimilar In Notice Fight

By Britain Eakin (July 6, 2020, 7:10 PM EDT) -- Genetech's bid to block Amgen from marketing a biosimilar version of its blockbuster cancer drug Avastin fizzled out Monday, with a Federal Circuit panel upholding a Delaware federal judge's decision that Amgen Inc. gave proper notice before going to market.

The precedential opinion shot down Genentech's argument that the Biologics Price Competition and Innovation Act's requirement that biosimilar makers provide 180 days notice before marketing their product was re-triggered when Amgen changed the manufacturing location and label of its biosimilar Mvasi.

Amgen launched Mvasi in July 2019, and it had sales of $121 million last year, according to Amgen's annual report....

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