Amgen: FDA Committee To Review Data Supporting BLA For ABP 215 - Quick Facts

(RTTNews) - Amgen (AMGN) and Allergan plc. (AGN) announced that the Oncologic Drugs Advisory Committee of the U.S. FDA will review data supporting the Biologics License Application for ABP 215, a biosimilar candidate to Avastin (bevacizumab), on July 13, 2017. The FDA has set a Biosimilar User Fee Act target action date of Sept. 14, 2017, for ABP 215.

The FDA Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase 3 study in patients with non-squamous non-small cell lung cancer. The Phase 3 study met its primary endpoint showing clinical equivalence to bevacizumab. The company said the safety and immunogenicity of ABP 215 were also comparable to bevacizumab.