Amgen And Allergan Submit Biosimilar BLA For ABP 980 To FDA

(RTTNews) - Amgen (AMGN) and Allergan plc. (AGN) announced the submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration for ABP 980, a biosimilar candidate to Herceptin or trastuzumab. Amgen and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval.

ABP 980 is a biosimilar candidate to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that targets HER2. Trastuzumab is approved for the treatment of HER2-positive adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer in the U.S.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one of which has been approved by the FDA.