Biocon gets GMP compliance certificate for Biologics facilities

Biocon Limited’s subsidiary Biocon Biologics India Ltd has received a certificate of GMP compliance from EMA for multiple Biologics drug substance (DS) and drug product (DP) manufacturing facilities at Biocon Park, Bengaluru.

These facilities are used for the manufacturing of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets and were inspected in March 2020.

This has led the capacities of Biocon Biologics to grow multi-fold to address the growing needs of patients in EU markets for Trastuzumab commercialised in March 2019 and for Pegfilgrastim expected to be commercialised soon. Currently, it’s another biosimilar Bevacizumab, which is the marketing authorisation application and is under review by European authorities. The above certification would enable its further approval process.

Biocon Biologics had expanded the production capacity for Pegfilgrastim drug substance through the new B-4 manufacturing facility in Bengaluru, which received USFDA approval in November 2019 and started commercial operations subsequently. In 2019, it had also expanded production capacity for the biosimilar Trastuzumab through a new drug product (DP) filling line at B-2 biologics facility, which received USFDA approval in October 2019.

Biocon Biologics, through its partner Mylan, has commercialised two of its co-developed biosimilars, Trastuzumab and Insulin Glargine, in EU. The commercialisation of biosimilar Pegfilgrastim in EU is imminent. It aims to impact five million patient lives and cross a revenue milestone of USD 1 billion in FY22.

On Tuesday, the stock of Biocon has opened at Rs 334 as against its previous close of Rs 331.55.