ABP 215 regulatory update

Amgen and Allergan said they submitted an MAA to EMA 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 EU. Last year, Amgen and Allergan said APB 215 showed clinical equivalence to Avastin, meeting the primary and secondary endpoints in a Phase III trial to treat non-small cell lung cancer (NSCLC) (see BioCentury, Sept. 28, 2015). Avastin, a humanized IgG1 mAb against VEGF, is approved in the EU to treat NSCLC, breast cancer, colorectal cancer, cervical cancer, ovarian cancer and renal cell carcinoma (RCC)...