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Biocon Biologics Bengaluru facility gets EU GMP certification for Bevacizumab

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-04-29T11:47:34+05:30  |  Updated On 29 April 2023 11:49 AM IST
Phase 3 study comparing Yesintek with Stelara in adult patients with chronic plaque psoriasis shows positive results: Biocon Biologics
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Bangalore: 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.

Bevacizumab is indicated to treat various types of cancers and a specific eye disease.

“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.
Read also: Biocon Academy conducts Graduation Ceremony for 185 students across four programs

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

bioconbiocon biologicsbiocon newsbevacizumab
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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