Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA ™…

sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued group • Filing acceptance reinforces Samsung Bioepis and Organon's commitment to provide better…#phase4 #humira #samsungbioepis #organon #incheon #jerseycity #samsungbioepiscoltd #organonco #ogn #fda

Source: Reuters: Health - November 7, 2023 Category: Consumer Health News Source Type: news