Professor Sarfaraz K. Niazi achieved a historic regulatory milestone with the FDA accepting the waiver of clinical efficacy studies (CESs) for monoclonal antibody biosimilars. This paradigm shift relies on analytical similarity and immunogenicity data instead of costly and lengthy efficacy trials, drastically reducing development costs and accelerating approvals. The initial application involves a biosimilar to Stelara (ustekinumab). This regulatory breakthrough promises to enable smaller firms to enter the biosimilar market and improve patient access through lower drug costs, aligning U.S. policies with European agencies like the EMA and MHRA.