Biocon Biologics facility receives EU GMP certification for Bevacizumab

Biotechnology major Biocon announced that its Bengaluru-based plant of Biocon Biologics has received a Certificate of GMP Compliance for an additional product, biosimilar Bevacizumab.
Biocon Biologics’ facility has received a certificate of GMP compliance for Bevacizumab from the representative European inspection authority — Health Products Regulatory Authority (HPRA), Ireland.
The biosimilar is a drug used to treat a variety of cancers and eye problems.
“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,” a company spokesperson said in a statement.
According to the spokesperson, this (B3) plant, which is one of India’s largest monoclonal antibody (mAb) production facilities, acquired EU GMP Certification for manufacturing biosimilar Trastuzumab last year. Biocon Biologics is a Biocon Ltd. subsidiary.
The same facility received approval for the biosimilar Trastuzumab, a targeted cancer medicine also known as Herceptin, Herzuma, and Ontruzant, last year.
Source: Businesstoday

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