As of July 22, the FDA has approved 57 biosimilars for 17 reference biologics. It has been a decade since Sandoz filed its 351(k) application to become the first biosimilar marketed in the US. It seems like ages ago. Filed for approval on May 8, 2024, Zarxio® (filgrastim-sndz) was approved by the FDA on March … Continue reading A 10-Year Anniversary Assessment of FDA Biosimilar Approvals: Using the EMA as the Comparator