Mylan: EMA To Review MAA For Proposed Biosimilar Trastuzumab - Quick Facts

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. announced the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. The companies, which have co-developed the proposed biosimilar, anticipate this may be the first MAA for a Trastuzumab biosimilar accepted by the EMA for review.

The company's filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics and confirmatory efficacy/safety global clinical trials for Trastuzumab.