The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its goals for reviewing them. The guidance also describes the process for submitting supplements.
FDA states that “these supplement categories will help to ensure consistent processes for reviewing these supplements across review divisions.”
The guidance covers the six classification categories for supplements and their associated review performance goals that were established under the Biosimilar User Fee Amendments of 2022 (BsUFA III) commitment letter, released in September 2021. (RELATED: BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus 21 September 2021)…
