FDA decides not to approve Amgen biosimilar, at least for now

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FDA decides not to approve Amgen biosimilar, at least for now

By Staff Report / Friday, June 1st, 2018 / Comments Off on FDA decides not to approve Amgen biosimilar, at least for now

Amgen’s ABP980, a biosimilar of Genentech's cancer treatment Herceptin, was denied approval by the U.S. Food and Drug Administration, the company announced June 1. The Thousand Oaks biotech giant said it received a complete response letter from the FDA. The letters are sent out if the agency has decided not to approve a drug, containing…

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