ABP 215 regulatory update

Amgen and Allergan said they submitted a BLA to FDA for ABP 215, a biosimilar of Avastin bevacizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland). The partners said they believe the submission is the first for an Avastin biosimilar in the U.S. Avastin, a humanized IgG1 mAb against VEGF, is approved to treat non-small cell lung cancer (NSCLC), colorectal cancer, glioblastoma, cervical cancer, ovarian cancer and renal cell carcinoma (RCC). Amgen said the company will seek the biosimilar's approval in all indications not protected by exclusivity. Genentech was unable to give an expiration date for Avastin's patent coverage...