A closely watched patent battle

There’s an elaborate patent dance over biosimilar marketing rights playing out between Genentech and Amgen. And it could have broader implications on the timeline for getting cheaper alternatives to biosimilars to the market.

A federal appeals court is now deciding whether Amgen ought to halt sales of a biosimilar version of Genentech’s cancer drug, Avastin — based on a somewhat wonky interpretation of a law called the Biologics Price Competition and Innovation Act. The law requires that biosimilar companies provide notice to their name-brand rivals, and at least 180 days before marketing its medicine, STAT’s Ed Silverman writes.

Genentech has asserted that Amgen didn’t file the appropriate paperwork back in 2018, giving regulators an inaccurate picture of its manufacturing process. It wants Amgen to stop selling the Avastin biosimilar, called Mvasi, until it’s waited out another 180 days so that Genentech can, ostensibly, determine if any patents have been violated.

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