Posted by Michael Wonder on 08 Nov 2023
Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira
7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration Hadlima versus Humira-continued group.
Samsung Bioepis and Organon today announced that the US FDA has accepted for review the supplemental biologics license application for the interchangeability designation for Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira (adalimumab).
