Yusimry FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 15, 2023.

FDA Approved: Yes (First approved December 17, 2021)
Brand name: Yusimry
Generic name: adalimumab-aqvh
Dosage form: Injection
Company: Coherus BioSciences, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Yusimry (adalimumab-aqvh) 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.

• Yusimry is a biosimilar to Humira and does not have an interchangeability designation.
• Yusimry is a citrate free formulation approved in the following dosage forms:
  • Single-dose prefilled pen (Yusimry Pen): 40 mg/0.8mL
  • Single-dose prefilled glass syringe: 40 mg/0.8 mL
• Yusimry is administered via subcutaneous injection.
• The FDA approval of Yusimry is based on clinical data that demonstrates Yusimry is biosimilar to Humira.
• The product label for Yusimry 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.
• Yusimry is the seventh 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, Abrilada (adalimumab-afzb) in 2019, and Hulio (adalimumab-fkjp) in 2020.

Development timeline for Yusimry

Further information

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