BioCentury
ARTICLE | Clinical News

Pfizer receives CRL for Herceptin biosimilar

April 27, 2018 7:31 PM UTC

Pfizer Inc. (NYSE:PFE) received a complete response letter from FDA for a BLA for PF-05280014, the company’s biosimilar of Herceptin trastuzumab. Pfizer said FDA requested additional technical information unrelated to safety or clinical data, but declined to disclose additional information.

Spokesperson Thomas Biegi told BioCentury that Pfizer was seeking the biosimilar's approval to treat HER2-positive breast cancer and gastric cancer, the indications for which Herceptin is approved. The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) markets Herceptin, a humanized mAb against HER2...