FDA and EMA Biosimilar Approvals

A comparison of clinical testing requirements for 16 biosimilars approved by both the FDA and EMA found that among 10 biosimilars approved first by the EMA, 5 were approved by the FDA based on the same clinical trials, while 6 newer biosimilars received earlier FDA approval with increasingly streamlined requirements. These findings suggest the US biosimilar approval process has evolved to become more efficient and aligned with the European approach, potentially supporting faster growth of the US biosimilar market.