Idacio FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 21, 2023.

FDA Approved: Yes (First approved December 13, 2022)
Brand name: Idacio
Generic name: adalimumab-aacf
Dosage form: Injection
Company: Fresenius Kabi USA, LLC
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Idacio (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

• Idacio is a biosimilar to Humira and does not have an interchangeability designation.
• Idacio is a citrate free formulation approved in the following dosage forms:
  • Single-dose prefilled pen (Idacio Pen): 40 mg/0.8 mL
  • Single-dose prefilled glass syringe: 40 mg/0.8 mL
• Idacio is administered via subcutaneous injection.
• The FDA approval of Idacio is based on clinical data that demonstrates Idacio is biosimilar to Humira.
• The product label for Idacio 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.
• Idacio is the eighth FDA-approved Humira biosimilar, following the approvals of Yusimry (adalimumab-aqvh) in 2022, Hulio (adalimumab-fkjp) in 2020, Abrilada (adalimumab-afzb) in 2019, Hadlima (adalimumab-bwwd) in 2019, Hyrimoz (adalimumab-adaz) in 2018, Cyltezo (adalimumab-adbm) in 2017, and Amjevita (adalimumab-atto) in 2016.

Development timeline for Idacio

Further information

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