Mylan and Biocon's trastuzumab biosimilar submission accepted by EMA

25 August 2016

Netherlands-based generics major Mylan (Nasdaq: MYL) and Indian drugmaker Biocon (BSE: 532523) have had their regulatory submission for a trastuzumab biosimilar accepted by the European Medicines Agency (EMA).

Trastuzumab is sold by Genentech, a unit of Swiss pharma major Roche (VTX: ROG), under the name Herceptin, and is used to treat certain HER2-positive breast and gastric cancers.

A biosimilar version of the drug has already been made available in India, which prompted Roche to launch legal action against Biocon and Mylan.

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