Drug news

FDA accepts filing BLA of MYL 1401O, (Hertraz), biosimilar trastuzumab, to treat HER-2 positive breast cancer.- Mylan + Biocon

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Last updated:28th Jun 2017

Published:13th Jan 2017

Source: Pharmawand

Mylan N.V. and Biocon Ltd. announced that the FDA has accepted Mylan's biologics license application (BLA) for MYL 1401O, (Hertraz) a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.

Comment: The patents on Herceptin expire in the US in June 2019 and expired in Europe in July 2014.

Mylan and Biocon's proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA).

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