Yusimry FDA Approval History
Last updated by Judith Stewart, BPharm on May 27, 2025.
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:
Product Presentation Strength Biosimilar / Interchangeable Pre-Filled Syringe 40 mg / 0.8 mL Biosimilar Autoinjector 40 mg / 0.8 mL Biosimilar - 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.
Humira Biosimilars
Brand Name | Generic Name | Date of Approval |
Amjevita | adalimumab-atto | September 23, 2016 |
Cyltezo | adalimumab-adbm | August 25, 2017 |
Hyrimoz | adalimumab-adaz | October 30, 2018 |
Hadlima | adalimumab-bwwd | July 23, 2019 |
Abrilada | adalimumab-afzb | November 15, 2019 |
Hulio | adalimumab-fkjp | July 6, 2020 |
Yusimry | adalimumab-aqvh | December 17, 2021 |
Idacio | adalimumab-aacf | December 13, 2022 |
Yuflyma | adalimumab-aaty | May 23, 2023 |
Simlandi | adalimumab-ryvk | February 23, 2024 |
Development timeline for Yusimry
Date | Article |
---|---|
Dec 20, 2021 | Approval FDA Approves Yusimry (adalimumab-aqvh), a Biosimilar to Humira |
Further information
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