EMA Issues Statement of Non-Compliance for Biocon’s Biosimilar Manufacturing Facility

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization in the European Union for three biosimilar products: Fulphila (Pegfilgrastim), Ogivri (Trastuzumab), and Semglee (Insulin Glargine).  The French National Agency for Medicines and Health Products Safety (ANSM), on behalf of the European Medicines Agency (EMA), inspected Biocon’s Bengaluru product plant in March. The results of that inspection were posted last week, when the ANSM issued a Statement of Non-Compliance (NCS) based on good manufacturing practices (GMP) deficiencies.  Specifically, the inspection found “35 deficiencies, including 11 major deficiencies” in a variety of areas.  The ANSM recommended to the EMA that none of the 3 biosimilars manufactured prior to the issuance of the NCS be supplied to the European marketplace and that the European Union not approve the MA applications for the products in question while the NCS remains in force.

Biocon responded that it, along with its partner Mylan, would work with the authorities with the goal of an early re-inspection, and that it was committed to ensuring the highest level of quality for all of its products.