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BIO urges FDA to release guidance on biosimilars.

2015-01-12 14:31:03| Industrial Newsroom - All News for Today

Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. BIO calls on the FDA to release final guidance on processes and scientific criteria for approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining biosimilar to be interchangeable with its reference biological.

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