Professor Sarfaraz K. Niazi Secures First-Ever FDA Acceptance to Waive Clinical Efficacy Studies for Monoclonal Antibody Biosimilars
In a groundbreaking milestone for global healthcare and pharmaceutical innovation, Professor Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois at Chicago and founder of multiple biopharmaceutical enterprises, has secured thefirst-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars. This decision fundamentally redefines how biological drugs will be developed, approved, […]