7 December 2017 - The EMA has accepted for review of Mumbai-based pharmaceutical company USV Pvt. Ltd’s marketing application for biosimilar pegfilgrastim. 

The product is a biosimilar to Amgen Inc.’s chemotherapy drug Neulasta.

The development comes after the EMA accepted for review of Biocon Ltd and Mylan N.V.’s applications for biosimilars pegfilgrastim and trastuzumab on 30 November.

“Pegfilgrastim is the key product in the biosimilars portfolio that we are developing and acceptance of marketing authorization application by EMA is a significant milestone. We are also planning to file application for pegfilgrastim with the US FDA (Food and Drug Administration),” Prashant Tewari, managing director of USV told Mint.

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