Mylan (MYL), Biocon's Trastuzumab Biosimilar MAA Accepted for Review by EMA
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Mylan and Biocon Announce Regulatory Submission for Proposed Biosimilar Trastuzumab Accepted for Review by European Medicines Agency
August 25, 2016 6:30 AM EDTBENGALURU, India and HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan's MAA for the proposed biosimilar Pegfilgrastim was accepted for review by... More
