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.
- Abrilada is a biosimilar to Humira and has an interchangeability designation.
- Abrilada is a citrate free formulation approved in the following dosage forms:
- Single-dose prefilled pen (Abrilada Pen): 40 mg/0.8 mL
- Single-dose prefilled glass syringe: 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL
- Single-dose glass vial for institutional use only: 40 mg/0.8 mL
- Abrilada is administered via subcutaneous injection.
- The FDA approval of Abrilada was based on clinical data that demonstrates Abrilada is biosimilar to Humira.
- 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.
- 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
| Date | Article |
|---|---|
| Oct 5, 2023 | Approval FDA Grants Interchangeable Designation to Pfizer’s Biosimilar Abrilada |
| Aug 17, 2022 | FDA Accepts for Review Pfizer’s Supplemental Application for Abrilada™ (adalimumab-afzb) Interchangeability |
| Nov 18, 2019 | Approval FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira |
Further information
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