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Hyrimoz FDA Approval History

Last updated by Judith Stewart, BPharm on May 27, 2025.

FDA Approved: Yes (First approved October 30, 2018)
Brand name: Hyrimoz
Generic name: adalimumab-adaz
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Hyrimoz (adalimumab-adaz) is an anti-TNF-α monoclonal antibody biosimilar/interchangeable 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.

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 Hyrimoz

DateArticle
May  8, 2024Approval Select Strengths of Sandoz Biosimilar Hyrimoz Granted Interchangeability by FDA
Mar 21, 2023Approval Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation
Oct 31, 2018Approval FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira

Further information

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