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Hulio FDA Approval History

Last updated by Judith Stewart, BPharm on July 31, 2020.

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, Maintenance, Ulcerative Colitis, Plaque Psoriasis

Hulio (adalimumab-fkjp) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

  • 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.
  • The FDA approval of Hulio is based on clinical data that demonstrates Hulio is biosimilar to Humira.
  • Hulio is administered via subcutaneous injection.
  • 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

Jul  9, 2020Approval FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira

Further information

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