Samsung Bioepis, Organon Application (sBLA) Accepted for Biosimilar to Humira

 

• 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 access to biologic medicines for patients in the United States

https://www.globenewswire.com/news-release/2023/11/07/2775667/0/en/Samsung-Bioepis-Organon-Announce-FDA-Acceptance-of-Supplemental-Biologics-License-Application-sBLA-for-Interchangeability-Designation-for-HADLIMA-adalimumab-bwwd-a-Biosimilar-to-Hu.html