Biocon Biologics gets EMA nod to manufacture cancer drug in India
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Biocon Biologics, a subsidiary of Biocon, on Monday obtained approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab in India.
The firm, in an announcement, mentioned that the biosimilar Bevacizumab can be manufactured at its new multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru.
This approval will present important extra capability to deal with sufferers’ wants throughout the markets in Europe. The facility has beforehand obtained approval to manufacture biosimilar Trastuzumab in September 2022.
Further, the power additionally obtained Good Manufacturing Practice (GMP) Certificates of Compliance by the EMA, Biocon mentioned. The GMP certificates, issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA, had been additionally supplied to its insulin facility in Malaysia.
The GMP certifications in India and Malaysia “mirror Biocon Biologics’ continued compliance with the best requirements of high quality and our unwavering dedication to addressing affected person wants globally”, an organization spokesperson mentioned, in the assertion.
(With inputs from IANS)
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