Browsing Tag
Sarfaraz K. Niazi
2 posts
FDA acceptance of Sarfaraz Niazi’s biosimilar petition could reset the economics of monoclonal antibody approvals
FDA accepts Sarfaraz Niazi’s petition to waive costly clinical efficacy studies for monoclonal antibody biosimilars, reshaping drug affordability worldwide.
FDA accepts first biosimilar without clinical efficacy studies: Will this redefine global biologics access?
FDA waives efficacy trials for Stelara biosimilar, opening new doors for fast-track biosimilar access. Find out how this could reshape drug affordability worldwide.