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Simponi FDA Approval History

FDA Approved: Yes (First approved April 24, 2009)
Brand name: Simponi
Generic name: golimumab
Dosage form: Injection
Company: Centocor, Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis

Simponi (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:

  • Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
  • Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
  • Active ankylosing spondylitis (AS)
  • Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy
    • inducing and maintaining clinical response
    • improving endoscopic appearance of the mucosa during induction
    • inducing clinical remission
    • achieving and sustaining clinical remission in induction responders

Development Timeline for Simponi

DateArticle
May 15, 2013Approval FDA Approves Simponi to Treat Ulcerative Colitis
Apr 24, 2009Approval Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Jun 27, 2008Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Further information

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