FDA to pilot new biosimilar program under BsUFA III

Oct 3, 2022

The FDA announced that it will pilot a regulatory science program to advance the development of interchangeable products and improve the efficiency of biosimilar product development.  The program, set out briefly in the FDA’s Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), will comprise two demonstration projects.  The first will evaluate the data required to meet safety standards for interchangeability, and may include researching approaches other than switching studies to meet the interchangeability standard.   The second, evaluating opportunities to streamline biosimilar product development,  will take into account scientific advancements in analytical and pharmacological assessments, as well as experience with prior product development and marketed biosimilar products.  Both will investigate methodologies, such as in vitro and in silico methods, to predict immunogenicity.

The BsUFA provides a framework for the FDA to collect user fees from companies developing biosimilar and interchangeable biological products in return for committing to certain performance goals, which are periodically refreshed and reauthorised.  BsUFA III comprises the second reauthorisation under this framework, and commences in October 2022, running until September 2027.   As well as the science program, BsUFA III sets out a number of performance goals for the FDA, including review response times; procedures relating to clinical protocol evaluation, facilities inspection, FDA-sponsor meetings and human factors validation studies for biosimilar-device combination products;  and timeframes for the publication of a range of new or revised draft guidance documents.

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