Regulatory advisory Pharmaceutical Scientist Inc announced on Monday that Professor Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois at Chicago and founder of multiple biopharmaceutical enterprises, has secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars.

This decision is claimed to fundamentally redefine how biological drugs will be developed, approved, and made affordable for patients worldwide.

Professor Niazi's argument is that for decades, CESs have been a central -- and costly -- component of biosimilar approval, despite their inability ever to demonstrate meaningful failure outcomes. In numerous citizen petitions to the FDA and dozens of peer-reviewed publications advising the agency, Professor Niazi has argued that CESs add no scientific value to biosimilar evaluation, as analytical similarity and immunogenicity studies are sufficient to confirm biosimilarity. His advocacy has now culminated in the FDA's acceptance of this evidence-based paradigm shift, Pharmaceutical Scientist said.

Professor Niazi's biosimilar application for Stelara (ustekinumab) will be the first filed with the FDA without requiring any clinical testing, marking a precedent-setting regulatory breakthrough. Removal of CES requirements is expected to reduce biosimilar development costs by over 90%, accelerate approval timelines by more than 70%; empower small- and mid-sized companies to enter the biosimilar market, where entry had previously been limited to resource-rich pharmaceutical giants; and spur competitive pricing that mirrors the trajectory of generic small-molecule drugs, delivering widespread affordability to patients.

This decision aligns the FDA with the European Medicines Agency (EMA) and the UK's MHRA, which have already taken steps in line with Niazi's recommendations.