FDA Accepts Supplement Application for HADLIMA (Adalimumab Biosimilar)
The FDA has accepted the supplemental application for HADLIMA, a biosimilar to adalimumab.
Published: July 11, 2026
Updated: July 11, 2026
Author: Humanexa Intelligence
Therapeutic area: Immunology / Biosimilar
Company: AbbVie
Asset: Humira
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 landscape of biosimilars, particularly against AbbVie's Humira. This development may influence market dynamics and pricing strategies as Humira approaches patent expiration.
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Analysis
Monitor the timeline for FDA decision and any subsequent market entry strategies from Samsung Bioepis.
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