Biocon gets green light to manufacture biosimilars for EU

20 May 2020

Indian company Biocon (NSE: BIOCON) has received the certificate of good manufacturing practice (GMP) compliance from the European Medicines Agency (EMA) for the manufacture of biologics drug substance (DS) and drug product (DP) at its Bengaluru site.

These facilities are used for the manufacture of DS and DP for biosimilar drugs referencing Avastin (bevacizumab), Herceptin (trastuzumab) and Neulasta (pegfilgrastim), as well as secondary packaging of insulin glargine for European Union (EU) markets. They were inspected in March of this year.

"This approval will support the penetration of trastuzumab and pegfilgrastim in Europe"The approval expands Biocon’s capacities multi-fold to address the growing needs of patients in the EU for the trastuzumab biosimilar, which was commercialized in March 2019, and for the pegfilgrastim product, which is expected to reach the market soon.

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