Posted by Michael Wonder on 02 Dec 2017
European Medicines Agency accepts marketing authorisation applications for Mylan and Biocon's proposed biosimilars trastuzumab and pegfilgrastim
30 November 2017 - Mylan and Biocon today announced that the EMA has accepted for review Mylan's marketing authorisation applications for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim.
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 reinspection, which will be completed as part of the regulatory review process.
