Yuflyma FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 25, 2024.

FDA Approved: Yes (First approved May 23, 2023)
Brand name: Yuflyma
Generic name: adalimumab-aaty
Dosage form: Injection
Company: Celltrion USA
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Yuflyma (adalimumab-aaty) 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.

• Yuflyma is a biosimilar to Humira and does not have an interchangeability designation.
• Yuflyma is a high-concentration, low-volume, citrate free formulation approved in the following dosage forms:
  • Single-dose prefilled auto-injector (Yuflyma AI): 40 mg/0.4 mL
  • Single-dose prefilled syringe with safety guard : 40 mg/0.4 mL
  • Single-dose prefilled syringe: 40 mg/0.4 mL
• Yuflyma is administered via subcutaneous injection.
• The FDA approval of Yuflyma was based on clinical data that demonstrates Yuflyma is biosimilar to Humira.
• The product label for Yuflyma 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.
• Yuflyma is the ninth FDA-approved Humira biosimilar, following the approvals of Idacio (adalimumab-aacf) in 2022, 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 Yuflyma

Further information

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