Mylan Resubmits EMA Applications for Trastuzumab and Pegfilgrastim

EMA News

As we previously reported, earlier this year Biocon requested withdrawal and re-submission of its Marketing Authorization Applications for its trastuzumab and pegfilgrastim biosimilars with the European Medicines Agency (EMA), as part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s facility.  Today, Biocon’s partner Mylan re-submitted the applications to the EMA.  In a press release, Biocon stated that it has “completed the Corrective and Preventive Actions (CAPAs), including the facility modifications, in response to the [EMA’s] audit observations and expects these to be verified during re-inspection.”

Download PDF

Comments are closed.