Amgen and Allergan plc . announce the submission of a biologics license application (BLA) to the FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
Amgen and Allergan plc . announce the submission of a Biologics License Application (BLA) to the FDA for ABP 980, a biosimilar candidate to Herceptin (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.
Comment: The EU patent for Herceptin (trastuzumab) expired on 28 July 2014 and the US patent is estimated to expire in 2019. Competitors to ABP 980 include Hertraz from Mylan which has an Advisory Committee recommendation, Herzuma from Celltrion/Teva which is filed in the EU and is in Phase III trials in the US, PF 06439535 from Pfizer which is also in Phase III trials in the US and SB 3 from Biogen + Merck Inc. which is filed in the EU and is in Phase III trials in the US.
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