Abrilada FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on Nov 18, 2019.
FDA Approved: Yes (First approved November 15, 2019)
Brand name: Abrilada
Generic name: adalimumab-afzb
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Maintenance, Ulcerative Colitis, Plaque Psoriasis
Abrilada (adalimumab-afzb) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).
- The product label for Abrilada carries a Boxed Warning to alert health care professionals and patients of the increased risk of serious infections and malignancies.
- The FDA approval of Abrilada is based on clinical data that demonstrates Abrilada is biosimilar to Humira.
- Abrilada is administered via subcutaneous injection.
- Common adverse reactions (incidence >10%) include infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.
- Abrilada is the fifth FDA-approved adalimumab biosimilar, following the approvals of Amjevita (adalimumab-atto) in 2016, Cyltezo (adalimumab-adbm) in 2017, Hyrimoz (adalimumab-adaz) in 2018, and Hadlima (adalimumab-bwwd) in 2019.
Development Timeline for Abrilada
|Nov 18, 2019||Approval FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira|
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