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EMA Clarifies Questions Over Biosimilar Interchangeability

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

 
• By Dave Wallace

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.

EU Flag With Question Mark
The EMA has answered questions around biosimilar interchangeability • Source: Shutterstock

Questions over switching between multiple biosimilars and biologics, the relevance of complexity of biosimilar molecular structure to biosimilar switching, and national European switching policies have all been addressed in a fresh Q&A document published by the European Medicines Agency.

The Q&A follows up on the statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU that was published by the EMA and Heads of Medicines’ Agencies...

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