Biocon’s partner Mylan has resubmitted the Marketing Authorization Applications (MAAs) for its proposed biosimilar trastuzumab and pegfilgrastim with the European Medicines Agency (EMA) as per the administrative protocol. This follows the earlier withdrawal of both applications in response to the audit of our aseptic drug product facility by the designated European authority.
Biocon has completed the Corrective and Preventive Actions (CAPAs), including the facility modifications, in response to the audit observations and expects these to be verified during re-inspection.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
