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.
- Simlandi is indicated for:
- Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
- Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
- Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
- Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
- Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
- Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
- Plaque Psoriasis (Ps): Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
- Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients.
- Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. - Simlandi is approved in the following dosage forms:
Product Presentation Strength Biosimilar / Interchangeable Pre-Filled Syringe 20 mg / 0.2 mL Interchangeable Pre-Filled Syringe 40 mg / 0.4 mL Interchangeable Pre-Filled Syringe 80 mg / 0.8 mL Interchangeable Autoinjector 40 mg / 0.4 mL Interchangeable Autoinjector 40 mg / 0.4 mL Interchangeable Autoinjector 80 mg / 0.8 mL Interchangeable - Simlandi is administered via subcutaneous injection.
- The FDA approval of Simlandi is based on clinical data that demonstrates Simlandi is biosimilar to Humira.
- The product label for Simlandi 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.
- Simlandi is the tenth FDA-approved Humira 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 Simlandi
Date | Article |
---|---|
Feb 25, 2024 | Approval FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira |
Jun 28, 2023 | Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02 |
Further information
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