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EMA publishes new procedural advice document for biosimilar applicants

The European Medicines Agency (EMA) has published a new document providing procedural advice for users of the centralised procedure for biosimilar product applications.  The document consolidates information related to regulatory and procedural questions already available through the EMA website and existing regulatory documents. The document provides an overview of the EMA’s position on issues which are typically addressed during the course of pre-submission meetings.

A copy of the EMA document may be found here.