Amgen’s Herceptin biosimilar rejected by FDA

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Amgen’s Herceptin biosimilar rejected by FDA

By David Salazar - 06/05/2018
The Food and Drug Administration recently rejected Amgen’s Biologics License Application for a potential Herceptin biosimilar. The application for ABP 980 received a complete response letter from the FDA.

The FDA in December 2017 approved the first Herceptin biosimilar, Ogivri, developed by Mylan and Biocon. The two companies recently received approval for the first Neulasta biosimilar in the United States.

Amgen was unfettered by the response letter, pledging to continue to work to get the product approved.

“We will work closely with the FDA to bring this important medicine to patients in the U.S.,” Amgen said. “We do not expect this to impact our U.S launch plan.”