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US Capitol Capsule: Improving The Biosimilars Review Process: What's Needed?

This article was originally published in Scrip

Executive Summary

As the FDA gets ready to embark on the reauthorization process for the next round of the Biosimilar User Fee Act (BsUFA), which permits the agency to collect user fees from industry to aid in the reviews of biosimilars applications, known as 351(k)s, it wants to hear stakeholders' thoughts at a Dec. 18 public meeting on how well regulators are completing their program goals so far and what should be retained, changed or discontinued to improve performance.



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