FDA Issues two Biosimilar Final Guidance to Industry, “Classification Categories for Certain Supplements Under BsUFA III” and “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations”

U.S. Food and Drug Administration issued two final guidances for industry related to biosimilar development.

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).