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Abrilada FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 10, 2023.

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, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Abrilada (adalimumab-afzb) is a tumor necrosis factor (TNF) blocker interchangeable biosimilar to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Development timeline for Abrilada

Oct  5, 2023Approval FDA Grants Interchangeable Designation to Pfizer’s Biosimilar Abrilada
Aug 17, 2022FDA Accepts for Review Pfizer’s Supplemental Application for Abrilada™ (adalimumab-afzb) Interchangeability
Nov 18, 2019Approval FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira

Further information

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