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Amgen and Allergan submit biologics license application for ABP 980 to US FDA.

M2 PHARMA-August 3, 2017-Amgen and Allergan submit biologics license application for ABP 980 to US FDA


United States-based Amgen and Ireland-based Allergan have submitted a biologics license application for ABP 980, a biosimilar candidate to Herceptin (trastuzumab), to the US Food and Drug Administration (FDA), it was reported yesterday.

The submission includes analytical, pharmacokinetic and clinical data, and pharmacology and toxicology data. Amgen stated that both firms are collaborating on four oncology biosimilar medicines, including ABP 980.

ABP 980 is the second to be submitted for US FDA approval. It is a biosimilar candidate to trastuzumab, which is a recombinant DNA-derived humanised monoclonal immunoglobulin G1 kappa antibody that targets HER2 and has been approved for the treatment of HER2-positive adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer in the US.

Both companies are jointly working to develop and commercialise four oncology biosimilars. Of the 10 biosimilars in the Amgen range, one has been approved by the US FDA.

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Publication:M2 Pharma
Date:Aug 3, 2017
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