Biocon Receives EMA’s GMP Certification for Multiple Biosimilars Manufacturing Facilities in Bengaluru

Biocon Receives EMA’s GMP Certification for Multiple Biosimilars Manufacturing Facilities in Bengaluru

Shots:

  • Biocon has received the EMA’s Certificate of GMP compliance for multiple biologics drug substance (DS) and drug product (DP) manufacturing facilities at Biocon Park, Bengaluru. The facilities are used for the manufacture biosimilars: bevacizumab, trastuzumab, pegfilgrastim and secondary packaging of Insulin Glargine for EU and were inspected in Mar’2020
  • The approval expands Biocon’s capabilities and allows its trastuzumab and pegfilgrastim to enter in the EU. The company expects that the certification enables the approval of biosimilar bevacizumab in the EU, currently under review
  • Biocon and Mylan are commercializing trastuzumab and Insulin Glargine in the EU while commercialization of biosimilar pegfilgrastim is imminent.  Additionally, the company expanded its production capacity for pegfilgrastim DS and trastuzumab DP through the new B-4 and B-2 manufacturing facility, which received US FDA’s approval in Nov’2019 and Oct’2019 respectively

Click here ­to­ read full press release/ article | Ref: Biocon  | Image: Pinterest