Biocon Requests Withdrawal and Re-Submission of EMA Applications for its Trastuzumab and Pegfilgrastim Biosimilars

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing authorization in the European Union (EU) for those products.  We also posted here that in July 2017, 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 and issued a Statement of Non-Compliance based on good manufacturing practices deficiencies, and that Biocon indicated that it and Mylan would work with authorities with the goal of an early re-inspection.

On August 16th, Biocon announced that it requested withdrawal and resubmission of its EMA applications for its Trastuzumab and Pegfilgrastim biosimilars, as part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s facility.  Biocon stated that it is “on track to complete the corrective and preventative actions (CAPAs) by the end of this quarter and intends to seek re-inspection and re-submission thereafter.”