Infliximab biosimilar nets FDA approval

  • Drugs.com

  • Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Infliximab-axxq, a biosimilar to infliximab, has been approved by the FDA for the treatment of moderate to severe rheumatoid arthritis, moderate to severe Crohn's disease, moderate to severe ulcerative colitis, chronic severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Why this matters

  • Biosimilars may improve patient access to treatment because of improved affordability.

Key results

  • Infliximab-axxq showed high similarity and no clinically meaningful differences compared with infliximab in results from a pharmacokinetic similar study conducted in healthy subjects, as well as a comparative clinical study conducted in patients with moderate to severe rheumatoid arthritis.
  • The comparative clinical study included 558 patients randomly assigned to receive infliximab or infliximab-axxq with a primary endpoint of response difference of 20% improvement in American College of Rheumatology (ACR20) core set measurements at week 22.
    • Secondary endpoints included DAS28-CRP (Disease Activity Score 28-joint count C reactive protein) change from baseline and response difference of ACR20, ACR50, and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50.
    • Patients who transitioned from infliximab to infliximab-axxq at week 22 experienced similar safety and immunogenicity after the transition.