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FDA rebuffs third biosimilar Herceptin

June 1, 2018 8:53 PM UTC

Amgen Inc. (NASDAQ:AMGN) said Friday it received a complete response letter from FDA for ABP 980. This marks the third CRL the agency has issued for a biosimilar of Herceptin trastuzumab. Amgen declined to disclose details of the letter. ABP 980 is partnered with Allergan plc (NYSE:AGN). The European Commission approved ABP 980 as Kanjinti in May.

FDA has approved one biosimilar Herceptin -- Ogivri trastuzumab-dkst from Mylan N.V. (NASDAQ:MYL; Tel Aviv:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON). In the U.S., Ogivri is indicated for all cancer types on Herceptin's label, including HER2-positive breast cancer and metastatic gastric cancer. Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit market Herceptin, a humanized mAb against HER2 (see BioCentury Extra, Dec. 1, 2017)...

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