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EMA Clarifies Questions Over Biosimilar Interchangeability

Q&A Document Follows EMA-HMA Statement On Scientific Rationale Last Year

Executive Summary

Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

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