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BRIEF-U.S. FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab
January 11, 2017 / 1:53 PM / 10 months ago

BRIEF-U.S. FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

Jan 11 (Reuters) - Mylan NV

* U.S. FDA accepts biologics license application (BLA) for Mylan and Biocon’s proposed biosimilar trastuzumab

* Mylan NV- anticipated FDA goal date set under Biosimilar User Fee Act (BSUFA) is Sept. 3, 2017

* Mylan nv - Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by European Medicines Agency (EMA) Source text for Eikon: Further company coverage:

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