The Cancer Letter

Inside information on cancer research and drug development

Drugs & Targets

Mylan and Biocon submit BLA for biosimilar trastuzumab

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MYLAN N.V. and Biocon Ltd. announced submission of Mylan’s biologics license application for MYL-1401O, biosimilar trastuzumab, to the FDA through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the...

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