FDA issues two biosimilar final guidances to industry

The US Food and Drug Administration (FDA) yesterday issued two final guidances for industry related to biosimilar development. These guidances will help maintain a predictable and efficient review process for biosimilars, the agency noted.

The final guidance “Classification Categories for Certain Supplements Under BsUFA III” provides recommendations for biosimilar manufacturers as well as FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications under section 351(k) of the Public Health Service Act (PHS Act). This draft guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.