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Biosimilars Guidance On Interferon Beta From EMA Foreshadows Possible Joint EU/U.S. Approach

This article was originally published in The Pink Sheet Daily

Executive Summary

EMA’s biosimilars interferon beta guideline, which says that magnetic resonance imaging of disease lesions may be enough to demonstrate similarity. More important perhaps, it’s the first guidance issued under the watch of new EMA chief Guido Rasi, who strongly supports allowing single data package for EU and U.S. biosimilar medicines.

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