EMA Accepts Applications for Two Mylan and Biocon Biosimilars

On Friday, Biocon and Mylan announced that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars.  As we previously reported, Biocon had earlier requested withdrawal and resubmission of these applications, which it said was part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s facility.  Biocon’s press release states that it has completed the Corrective and Preventive Actions (CAPAs) that were outlined as a result of the audit process.  Dr. Arun Chandavarkar, Biocon’s CEO and Joint Managing Director, said that Biocon “expect[s] these CAPAs to be verified during inspection as part of the review process” for the trastuzumab and pegfilgrastim applications.