Professor Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois at Chicago, has secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars.
The decision from the FDA fundamentally redefines how biological drugs will be developed, approved and made affordable for patients worldwide.
For decades, CESs have been a central but costly part of biosimilar approval. They have also been unable to demonstrate meaningful failure outcomes, leading to numerous citizen petitions to the FDA plus several peer-reviewed publications advising the FDA to remove them from the approval process.
Professor Niazi had previously argued that CESs add no scientific value to biosimilar evaluation, as analytical similarity and immunogenicity studies are sufficient to confirm biosimilarity.
His biosimilar application for Stelara (ustekinumab) will be the first filed with the FDA without requiring any clinical testing.
The removal of CES requirements is expected to
- reduce biosimilar development costs by more than 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
- spur competitive pricing that mirrors the trajectory of generic small-molecule drugs, delivering widespread affordability to patients.
The FDA's decisions will align it with both the European Medicines Agency (EMA) and the UK's MHRA, which have already begun to follow Niazi's recommendations.
"This is a victory for science, for reason, and most importantly, for patients who deserve affordable access to biological medicines," said Professor Niazi. "It will fundamentally reshape the economics of biosimilars and expand access globally."
Professor Niazi is now encouraging mid-sized and small generic companies to enter the field of biosimilars, as the cost of their development will be readily affordable. This will allow for substantial price reduction, making them affordable to the majority of global patients.