Mylan and Biocon submits breast cancer drug application to USFDA

Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration. Biosimilar trastuzumab is a proposed biosimilar to branded Trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. HER2-positive breast cancer is a breast cancer that tests positive for […]

EMA accepts review for Mylan and biocon’s trastuzumab biosimilar

Mylan N.V. and Biocon Ltd. said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar version of biosimilar Trastuzumab, a medicine used to treat breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Mylan’s MAA for […]