04.10.25 -- U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance

Back in 2016, the U.S. had only approved four biosimilars, while Europe had 23. Join Joseph Pategou as he asks and answers, "Where does the U.S. biosimilars market stand now?"

The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

A recent survey by the International Society for Pharmaceutical Engineering found that an inadequate company culture raised the greatest barrier to digital maturity.