Abrilada FDA Approval History
Last updated by Judith Stewart, BPharm on May 27, 2025.
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:
Product Presentation Strength Biosimilar / Interchangeable Single-Dose Vial 40 mg / 0.8 mL Interchangeable Pre-Filled Syringe 10 mg / 0.2 mL Interchangeable Pre-Filled Syringe 20 mg / 0.4 mL Interchangeable Pre-Filled Syringe 40 mg / 0.8 mL Interchangeable Autoinjector 40 mg / 0.8 mL Interchangeable - 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.
Humira Biosimilars
| Brand Name | Generic Name | Date of Approval |
| Amjevita | adalimumab-atto | September 23, 2016 |
| Cyltezo | adalimumab-adbm | August 25, 2017 |
| Hyrimoz | adalimumab-adaz | October 30, 2018 |
| Hadlima | adalimumab-bwwd | July 23, 2019 |
| Abrilada | adalimumab-afzb | November 15, 2019 |
| Hulio | adalimumab-fkjp | July 6, 2020 |
| Yusimry | adalimumab-aqvh | December 17, 2021 |
| Idacio | adalimumab-aacf | December 13, 2022 |
| Yuflyma | adalimumab-aaty | May 23, 2023 |
| Simlandi | adalimumab-ryvk | February 23, 2024 |
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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