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Biocon Biologics Receives EMA Approval for New Biosimilar Facility

Biocon Biologics Receives Ema Approval For New Biosimilar Facility In Bengaluru

Bengaluru-based biopharma firm Biocon Biologics (BBL) has received approval from the European Medicines Agency (EMA) to produce biosimilar Bevacizumab at its new multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru. Bevacizumab is used to treat various cancers, including colon, rectal, non-small cell lung cancer (NSCLC), glioblastoma, and cervical cancer.

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This EMA approval will significantly enhance Biocon’s capability to meet patient needs across European markets. The Bengaluru facility was previously authorized to produce biosimilar Trastuzumab in September 2022.

Additionally, the EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for Biocon’s biosimilars manufacturing facility in Bengaluru and its insulin facility in Malaysia. These renewals follow routine GMP inspections conducted by the Health Products Regulatory Authority (HPRA) of Ireland, acting on behalf of the EMA.

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“These GMP certifications across our manufacturing sites in India and Malaysia reflect Biocon Biologics’ continued commitment to addressing patient needs globally,” said a company spokesperson.

Furthermore, Biocon announced that the US Food and Drug Administration (USFDA) issued three observations following a GMP inspection at its active pharmaceutical ingredients (API) manufacturing facility in Visakhapatnam, Andhra Pradesh, conducted on June 14, 2024. Biocon is set to provide a timely response to the USFDA regarding these observations.

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