Biocon intimates of resubmission of biosimilar trastuzumab and pegfilgrastim with EMA

Following completion of Corrective and Preventive Actions including facility modifications

Biocon announced that its partner Mylan has resubmitted the Marketing Authorisation Applications (MAAs) for the proposed biosimilar trastuzumab and pegfilgrastim with the European Medicines Agency as per the administrative protocol. This follows the earlier withdrawal of both applications in response to the audit of aseptic drug product facility by the designated European Authority. Biocon has completed the Corrective and Preventive Actions (CAPAs), including the facility modifications, in response to the audit observations and expects these to be verified during re-inspection.

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