The U.S. Food and Drug Administration (FDA) granted a supplemental efficacy approval for adalimumab-adbm (Amjevita) on May 20, 2025. This action, designated as BLA 761058 S-31, specifically addresses the efficacy of the drug.
Background
Adalimumab is a well-established monoclonal antibody that targets tumor necrosis factor alpha (TNF-alpha). It is widely used for various inflammatory conditions. Adalimumab-adbm (Amjevita), developed by BOEHRINGER INGELHEIM, is a biosimilar to reference adalimumab, which is marketed under various brand names, including Humira. This supplemental approval by the FDA pertains to the efficacy class of the drug, indicating a review of its effectiveness.
What this means
This supplemental efficacy approval for adalimumab-adbm confirms or expands upon its demonstrated effectiveness for its approved indications. Such approvals are important for ensuring that the drug continues to meet regulatory standards for its intended therapeutic uses, providing clinicians and patients with updated information on its performance and scope of use.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for Biologics License Application (BLA) 761058, supplemental application S-31, was recorded on May 20, 2025, and is accessible via accessdata.fda.gov.