Hulio FDA Approval History
Last updated by Judith Stewart, BPharm on March 26, 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:
- Injection: 40 mg/0.8 mL in a single-dose prefilled pen (Hulio Pen)
- Injection: 40 mg/0.8 mL in a single-dose prefilled plastic syringe
- Injection: 20 mg/0.4 mL in a single-dose prefilled plastic syringe
- 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, following the approvals of Amjevita (adalimumab-atto) in 2016, Cyltezo (adalimumab-adbm) in 2017, Hyrimoz (adalimumab-adaz) in 2018, Hadlima (adalimumab-bwwd) in 2019, and Abrilada (adalimumab-afzb) in 2019.
Development timeline for Hulio
| Date | Article |
|---|---|
| Jul 9, 2020 | Approval FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira |
Further information
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