Big Molecule Watch
September 6, 2016

EMA Accepts Mylan and Biocon’s MAA for a Herceptin (Trastuzumab) Biosimilar

Last week, Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Genentech’s Herceptin (trastuzumab). Trastuzumab is indicated in Europe to treat certain breast cancers and gastric cancers that overexpress the HER2 protein. As we reported previously, Mylan and Biocon presented Phase III data regarding their trastuzumab biosimilar in June at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.

This latest application is Mylan and Biocon’s second MAA submission for a biosimilar drug arising from the two companies’ collaboration to be accepted by the EMA in the last month.

Stay tuned for further coverage of biosimilar applications at Big Molecule Watch.