Simlandi FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 26, 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 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 a biosimilar to Humira and has an interchangeability designation.
• Simlandi is a high-concentration, citrate free formulation approved in the following dosage form:
  • 40 mg/0.4 mL single-dose autoinjector.
• 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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