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Mylan, Biocon submit application for Herceptin biosimilar


PITTSBURGH and BENGALURU, India — Mylan and Biocon on Tuesday announced that they had submitted a biologics license application to the Food and Drug Administration for their proposed biosimilar of Herceptin (trastuzumab). The companies believe their submission has the potential to be the first of a proposed biosimilar for the drug in the United States. 


“The FDA submission for biosimilar trastuzumab marks Mylan's first FDA biosimilar submission from our broad portfolio of biosimilar products in development and our product has the opportunity to be the first biosimilar trastuzumab approved in the U.S.,” Mylan president Rajiv Malik said. “Our trastuzumab biosimilar is already being sold in 11 developing markets, including India, and we look forward to bringing the product to market in the U.S. and Europe upon approval.”


Mylan and Biocon have partnered on a broad portfolio of biosimilar and insulin products, and their trastuzumab biosimilar is one of six biologic products co-developed by the companies for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.


“The submission of our proposed biosimilar trastuzumab with the U.S. FDA is an important milestone of Biocon and Mylan's joint global biosimilars program and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe,” Biocon CEO and joint managing director Arun Chandavarkar said. “Cancer patients in India and emerging markets have benefited with our trastuzumab and this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools.”


Currently, there are five approved biosimilars in the U.S., including a follow-on biologic of insulin glargine, but there is only one approved biosimilar of a monoclonal antibody, (the class of drugs to which Herceptin belongs) — Amgen’s Amjevita (adalimumab-atto), a biosimilar of Humira (adalimumab). 


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