FDA Accepts Supplement Application for HADLIMA by Samsung Bioepis
The FDA has accepted the supplemental application for HADLIMA (BLA761059), a biosimilar to adalimumab.
Published: July 31, 2026
Updated: July 31, 2026
Author: Humanexa Intelligence
Therapeutic area: Immunology / Biosimilar
Company: AbbVie
Asset: HADLIMA
Regulatory TimelineREG
Fast Track
Breakthrough
Priority Review
PDUFA
Approval
Company
AbbVie
Asset
Signal assessment
Signal strength
high
Confidence level
moderate
Signalhigh
Confidencemoderate
Why it matters
The FDA's acceptance of the supplemental application for HADLIMA signifies a critical step in the competitive biosimilar landscape, particularly against AbbVie's Humira. This development necessitates a strategic reassessment of existing adalimumab products and market positioning.
Recommended action
Humanexa recommends Monitor.
Analysis
Monitor the timeline for FDA review and any subsequent approval announcements for HADLIMA.
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