25 August 2016 - Mylan and Biocon announced today that the 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.

This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan's MAA for the proposed biosimilar pegfilgrastim was accepted for review by EMA.

Mylan and Biocon, which have co-developed this proposed biosimilar, anticipate that this may be the first marketing authorization application for a trastuzumab biosimilar accepted by the EMA for review.

This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trials for trastuzumab. The PK study had demonstrated measured bioequivalence of Mylan's and Biocon's proposed trastuzumab biosimilar relative to that of the reference drug. The second study, the 'HERITAGE Study', evaluated the efficacy, safety and immunogenicity of the proposed biosimilar trastuzumab in comparison to branded trastuzumab.

Read Mylan press release