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Yusimry FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 2, 2022.

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

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, and plaque psoriasis.

  • 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.
  • The FDA approval of Yusimry is based on clinical data that demonstrates Yusimry is biosimilar to Humira.
  • Yusimry is administered via subcutaneous injection.
  • 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 Hulio (adalimumab-fkjp) in 2020, 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 Yusimry

Dec 20, 2021Approval FDA Approves Yusimry (adalimumab-aqvh), a Biosimilar to Humira

Further information

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