Skip to main content

Simlandi FDA Approval History

Last updated by Judith Stewart, BPharm on May 6, 2025.

FDA Approved: Yes (First approved February 23, 2024)
Brand name: Simlandi
Generic name: adalimumab-ryvk
Dosage form: Injection
Company: Alvotech and Teva Pharmaceutical Industries Ltd.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Simlandi (adalimumab-ryvk) is a tumor necrosis factor (TNF) blocker interchangeable 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.

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 Simlandi

DateArticle
Feb 25, 2024Approval FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira
Jun 28, 2023Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.