BsUFA II Goals Include Enhanced Review Process, Restructured Fees

The FDA hopes to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability.

These are among the several proposed performance goals for the next version of BsUFA, which is expected to take effect once the current version of the five-year authorization expires in September 2017. Congress, however, must reauthorize BsUFA with the performance goals before the expiration.

Under the agency’s proposal, covering fiscal years 2018 to 2022, the FDA will review biosimilar products using a review structure similar to the one used for new molecular entities and biologics, which run on 12-month cycles.