Biotechnology major Biocon on Friday said the Bengaluru-based plant of Biocon Biologics has received EU GMP approval for a biosimilar product, Bevacizumab.
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“Biocon Biologics’ integrated, multi-product, monoclonal antibodies (mAbs) Drug Substance manufacturing facility (B3) at Biocon Park, Bengaluru, has received a Certificate of GMP Compliance for an additional product, biosimilar Bevacizumab, from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland" a company spokesperson said in a statement.
Bevacizumab is indicated for the treatment of various types of cancers and a specific eye disease.
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This approval reflects Biocon Biologics’ compliance with the highest international regulatory standards and enables the Company to continue addressing the needs of patients in the EU through its high-quality products.
“This (B3) facility, which is one of India’s largest monoclonal antibodies (mAbs) manufacturing facilities, had received the EU GMP Certification for manufacturing biosimilar Trastuzumab last year. It was also awarded the ‘Facility of the Year Award’ (FOYA) with an ‘Honourable Mention’, by the International Society for Pharmaceutical Engineering (ISPE) in 2021,” the spokesperson added.
Biocon Biologics is a subsidiary of Biocon Ltd.
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