Biocon Biologics India receives EU GMP Certification for multiple biosimilar manufacturing facilities
Biocon gained 0.57% to Rs 333.45 after its subsidiary received EU GMP Certification for multiple Biosimilars manufacturing facilities in Bengaluru.
Biocon before market hours today, 19 May 2020 announced that its subsidiary Biocon Biologics India has received the certificate of Good Manufacturing Practice (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, Biocon said.
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 enable the approval process of biosimilar Bevacizumab, the Marketing Authorization Application for which is currently under review by the European authorities.
Biocon Biologics is a subsidiary of Biocon. It is uniquely positioned as a fully integrated 'pure play' biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions.
Dr Christiane Hamacher, CEO & Managing Director, Biocon Biologics India, said, 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.
Biocon's consolidated net profit declined 42.3% to Rs 123.40 crore on a 3.4% rise in net sales to Rs 1581 crore in Q4 March 2020 over Q4 March 2019.
Biocon is an innovation-led global bio-pharmaceuticals company. Biocon has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.
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