BIO Says BsUFA II Appraisal Must Include Third-Party Evaluator

A third-party evaluator should be used to assess the expanded communications program proposed in the next generation of the FDA’s biosimilar user fees, according to BIO.

The agency is proposing a new model for reviewing 351(k) applications, including more time for communication between review teams and sponsors through development meetings during submissions.

In a comment on the draft proposal, BIO said it agrees with the agency’s underlying aim of extending the transparency measures established under PDUFA to biosimilars, but said a third-party evaluation of whether the program achieved its goals is vital to its success.