Amgen, Allergan submit BLA for Herceptin biosimilar

In late July, Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) submitted a BLA to FDA for ABP 980, a biosimilar of Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. The company declined to disclose which indications the BLA seeks approval for or whether it parallels the MAA submitted to EMA in March, but said it had been studied to treat HER2-positive early breast cancer (see BioCentury, April 6).

Amgen and Allergan are partnered to develop 4 oncology biosimilars, including ABP 980, under a 2011 deal...