FDA seeks comments on specific guidances for biosimilars

The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.”

This notice establishes a public docket seeking comments from interested parties on determining whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products (eg, monoclonal antibodies), or by developing product-specific guidance documents (eg, adalimumab products).

As part of the Biosimilar User Fee Amendment (BsUFA III program, the FDA has updated its biosimilar action plan and is revisiting how best to advance the development of new biosimilar products. FDA guidance can enhance scientific and regulatory clarity for the biosimilar product development community and represents the agency’s current thinking on a matter.