Biocon Biologics Bengaluru facility gets EU GMP certification for Bevacizumab

Published On 2023-04-29 06:17 GMT   |   Update On 2023-04-29 06:19 GMT
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BangaloreBiocon 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.

Bevacizumab is indicated to treat 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," a company spokesperson said in a statement.
This (B3) facility, 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.

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. Biocon Biologics has eight commercialized products in global markets. The company has a portfolio of biosimilar assets, including insulins, monoclonal antibodies and conjugated recombinant proteins in therapeutic areas such as diabetology, oncology, immunology, and ophthalmology, which is one of the broadest and deepest biosimilar in the industry. Biocon Biologics has invested over USD 1 billion to date in R&D and global scale manufacturing and has end-to-end capabilities for producing drug substance, drug product and delivery devices across multiple sites in India and Malaysia. The company’s products are marketed globally through a hybrid commercial model with a combination of direct presence, strategic partnerships and distributor tie-ups.

Read also: Biocon Biologics bags 'ABEA : Bioprocessing Excellence in South Asia' Award

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