BsUFA III Talks Begin With Regulatory Science Disagreement

Brand trade group negotiators don’t support a biosimilar regulatory science proposal from the biosimilar and generic drug trade groups.

Anti-recessionary injection (vaccination) by hundred dollar denomination close up on a black background
Negotiations to extend BsUFA another five years began in March. • Source: Shutterstock

Biosimilar user fee reauthorization negotiators couldn’t avoid disagreement during their first session, as two industry factions emerged over regulatory science issues.

Representatives of the Biosimilars Forum and the Association for Accessible Medicines (AAM) and its Biosimilars Council, which advocate for biosimilars and generic drugs, discussed a biosimilar regulatory science proposal during a 16 March

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