Hulio FDA Approval History
Last updated by Judith Stewart, BPharm on May 27, 2025.
FDA Approved: Yes (First approved July 6, 2020)
Brand name: Hulio
Generic name: adalimumab-fkjp
Dosage form: Injection
Company: Mylan Pharmaceuticals Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis
Hulio (adalimumab-fkjp) is a tumor necrosis factor (TNF) blocker 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.
- Hulio is a biosimilar to Humira and has an interchangeability designation.
- Hulio is a citrate free formulation approved in the following dosage forms:
Product Presentation Strength Biosimilar / 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 - Hulio is administered via subcutaneous injection.
- The FDA approval of Hulio was based on clinical data that demonstrates Hulio is biosimilar to Humira.
- The product label for Hulio 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.
- Hulio is the sixth 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 Hulio
| Date | Article |
|---|---|
| Jul 9, 2020 | Approval FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.