Approval by the EMA will significantly enhance the capability to meet patient needs across European markets. The facility was previously authorised to produce biosimilar Trastuzumab in September 2022 | Photo: X@BioconBiologics
Bengaluru-based biopharma firm Biocon Biologics (BBL) has been granted approval by the European Medicines Agency (EMA) to produce biosimilar Bevacizumab at its newly established multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru.
Bevacizumab is used to treat various forms of cancer, including colon and rectal cancer (cancer that begins in the large intestine), non-small cell lung cancer (NSCLC), glioblastoma (a type of cancerous brain tumour), and cervical cancer.
Approval by the EMA will significantly enhance the capability to meet patient needs across European markets. The facility was previously authorised to produce biosimilar Trastuzumab in September 2022.
Biocon has announced that 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 EMA.
“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.
Last week, Biocon announced that the US Food and Drug Administration (USFDA) had issued three observations following a good manufacturing practices (GMP) inspection at its active pharmaceutical ingredients (API) manufacturing facility in Visakhapatnam, Andhra Pradesh.
The inspection, held on June 14, 2024, concluded with these observations. Biocon stated that it will provide a timely response to the USFDA.
First Published: Jun 24 2024 | 3:04 PM IST
