Professor Sarfaraz K. Niazi has secured a historic regulatory milestone with the FDA’s acceptance of a biosimilar application without requiring clinical efficacy studies (CESs). This breakthrough, a first for monoclonal antibody biosimilars, particularly targets the Stelara biosimilar (ustekinumab). Niazi’s long-standing advocacy argued analytical and immunogenicity data suffice for biosimilarity, which could reduce development costs by 90% and accelerate approvals, enhancing market competition and drug affordability globally. The FDA’s decision aligns with regulatory approaches by EMA and MHRA, promising transformative impact on biopharmaceutical innovation.