The US FDA is seeking information and comments to assist it in assessing how best to advance the development of new biosimilars, as part of the Biosimilar User Fee Amendments of 2022. The deadline for submitting comments is 23 October 2024.
Specifically, the FDA is seeking input on the following questions:
- Which would be more useful for accelerating biosimilar development: guidance documents that focus on a particular product (product-specific guidance), or guidance documents that are cross-cutting for a class of biosimilar products (product class-specific guidance) such as monoclonal antibodies?
- Should FDA focus on development of guidance documents for biological products (or classes of biological products) for which there are no approved biosimilars? Or would it be useful for FDA to continue to develop guidance on biosimilar development programs even after one or more biosimilar products have been approved for that biological product or class of biological products?
Instructions for submitting comments electronically or by paper are provided here.