Biocon Biologics receives EU GMP certification

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Biocon Biologics receives EU GMP certification for multiple biosimilars manufacturing facilities in Bengaluru

Biocon Ltd, Asia’s premier biopharmaceuticals company, announced recently that its subsidiary Biocon Biologics India Ltd. has received the 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 manufacture 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 approval expands Biocon Biologics’ capacities multi-fold to address the growing needs of patients in the EU markets for Trastuzumab commercialized in March 2019 and for Pegfilgrastim expected to be commercialized soon. This certification would further enable the approval process of our biosimilar Bevacizumab, the Marketing Authorization Application for which is currently under review by the European authorities.

Dr Christiane Hamacher, CEO & Managing Director, Biocon Biologics India Ltd, said, “We are extremely pleased with the EU GMP certification for our Biologics DP and DS manufacturing facilities in Bengaluru. This approval will support the penetration of Trastuzumab and Pegfilgrastim in Europe. This certification is expected to further enable the approval of biosimilar Bevacizumab in the EU. We remain committed to enhance access to our high quality biosimilars and global standards of quality and compliance and reaching the milestone of USD 1 billion in revenues in FY22. ”

Biocon Biologics has been making continued investments in building global scale, cost-competitive, complex manufacturing capabilities to address market opportunities worldwide. We expanded our production capacity for Pegfilgrastim Drug Substance through the new B-4 manufacturing facility in Bengaluru, which received U.S. FDA approval in November 2019 and started commercial operations subsequently. In 2019, we also expanded production capacity for our biosimilar Trastuzumab through a new Drug Product (DP) filling line at the B-2 biologics facility, which received U.S. FDA approval in October 2019.

Biocon Biologics, through its partner Mylan, has commercialized two of its co-developed biosimilars, Trastuzumab and Insulin Glargine, in EU. The commercialization of biosimilar Pegfilgrastim in the EU is imminent. These approvals further strengthen our ability to bring products to patients in EU. Going forward, through our strong portfolio of in-market and in-review biosimilars we will pursue the path of growth in EU, where the market for biosimilars is sizable and growing.

Biocon Biologics is committed to serve the needs of patients, people and partners by providing innovative affordable healthcare solutions going beyond the product. It aims to impact 5 million patient lives and cross a revenue milestone of USD 1 billion in FY22 .

Tags : #BioconBiologics #USFDA #DrChristianeHamacher #AffordableHealthcare

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