Biocon Biologics India receives EU GMP Certification for multiple biosimilar manufacturing facilities
Biocon Ltd announced on Tuesday
its subsidiary Biocon Biologics India Ltd. has received the Certificate of GMP (good manufacturing practices) compliance from EMA (European Medicines Agency) for multiple biologics drug substance (DS) and drug product (DP) manufacturing facilities here.
These facilities are used for manufacturing DS and DP for biosimilars (Bevacizumab, Trastuzumab and Pegfilgrastim) and secondary packaging of Insulin Glargine for EU (European Union) markets, and were inspected in March 2020, the Bengaluru-headquartered biopharmaceuticals company said in a statement.
This approval expands Biocon Biologics capacities multi- fold to address the growing needs of patients in the EU markets for Trastuzumab commercialised in March 2019 and for Pegfilgrastim expected to be commercialized soon , it said.
This certification would further enable the approval process of our biosimilar Bevacizumab, the marketing authorisation application for which is currently under review by the European authorities, Biocon said.
Biocon Biologics aims to cross a revenue milestone of USD one billion in FY22, the statement added.
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