EMA Releases New Biosimilar Q&A Guidance
The European Medicines Agency (EMA) has published a new guidance document that brings together in a single place a number of regulatory and procedural questions on biosimilars.
It provides an overview of the agency position on issues which are typically addressed during Pre-Submission Meetings. The agency notes that the document is for procedural advice only, and should be read in conjunction with the "Notice to Applicants" in the agency's Rules Governing Medicinal Products in the European Union.
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