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Amjevita FDA Approval History

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

FDA Approved: Yes (First approved September 23, 2016)
Brand name: Amjevita
Generic name: adalimumab-atto
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Amjevita (adalimumab-atto) an anti-TNF-α monoclonal antibody biosimilar/interchangeable to Humira indicated 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 Amjevita

DateArticle
Jan 31, 2023Amjevita™ (adalimumab-atto), First Biosimilar To Humira®, Now Available In The United States
Sep 23, 2016Approval FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira
Jul 12, 2016Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab
Jun 13, 2016Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab
Jan 25, 2016FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501
Nov 25, 2015Amgen's First Biosimilar Biologics License Application for ABP 501 Submitted to FDA

Further information

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