Simlandi FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 10, 2024.

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 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.

• 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:
  - single-dose autoinjector: 40 mg/0.4 mL (interchangeable)
  - single-dose prefilled glass syringe 20 mg/0.2 mL (biosimilar)
  - single-dose prefilled glass syringe 40 mg/0.4 mL (interchangeable)
  - single-dose prefilled glass syringe 80 mg/0.8 mL (biosimilar)
• The 40 mg/0.4 mL single-dose autoinjector and single-dose prefilled glass syringe have an interchangeable designation and the single-dose prefilled glass syringe in 20 mg/0.2 mL and 80 mg/0.8 mL strengths have a biosimilar designation.
• 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, following the approvals of Yuflyma (adalimumab-aaty) in 2023, Idacio (adalimumab-aacf) in 2022, Yusimry (adalimumab-aqvh) in 2022, Hulio (adalimumab-fkjp) in 2020, Abrilada (adalimumab-afzb) in 2019, Hadlima (adalimumab-bwwd) in 2019, Hyrimoz (adalimumab-adaz) in 2018, Cyltezo (adalimumab-adbm) in 2017, and Amjevita (adalimumab-atto) in 2016.

Development timeline for Simlandi

Further information

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