Mylan N.V. and Biocon announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applicat- ions (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim. Trastuzumab is used to treat certain HER2-positive breast and gastric cancers. Pegfilgrastim is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
EMA acceptance of the submissions follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon's drug product facility. Biocon has completed the Corrective and Preventive Actions (CAPAs) outlined as a result of the audit observations. The CAPAs will be confirmed during re-inspection, which will be completed as part of the regulatory review process.
Good Manufacturing Practice (GMP) compliance certificates for Biocon's two drug substance manufacturing facilities in Bangalore have been issued previously. Approval of these sites is key in the development and approval process as drug substance manufacture is core to the production of the actual biologic product in GMP compliance.
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.