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Simponi Aria FDA Approval History

FDA Approved: Yes (First approved July 18, 2013)
Brand name: Simponi Aria
Generic name: golimumab
Dosage form: Injection
Company: Janssen Biotech, Inc.

Simponi Aria (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) in patients 2 years of age and older
  • Adult patients with active Ankylosing Spondylitis (AS)
  • Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older

Development Timeline for Simponi Aria

DateArticle
Sep 30, 2020ApprovalSimponi Aria (golimumab) Approved by the FDA for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
Oct 20, 2017ApprovalFDA Approves Simponi Aria (golimumab) for the Treatment of Adults With Active Psoriatic Arthritis or Active Ankylosing Spondylitis
Jul 19, 2013ApprovalSimponi Aria (golimumab) for Infusion Receives FDA Approval for Treatment of Moderately to Severely Active Rheumatoid Arthritis

Further information

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