Adalimumab biosimilar gains FDA approval

  • Drugs.com

  • Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • The FDA approved adalimumab-afzb (Abrilada), a biosimilar to adalimumab (Humira), for treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.

Why this matters

  • Biosimilars such as adalimumab-afzb may lead to cost savings and help improve patient access to treatment options.

Key results

  • Approval was based on review of a comprehensive data package.
  • In the REFLECTIONS B538-02 clinical comparative study, adalimumab-afzb was found to have no clinically meaningful differences in efficacy, safety, or immunogenicity compared with adalimumab, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.
  • In addition, adalimumab-afzb is indicated for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
  • Adalimumab-afzb is the fifth approved adalimumab biosimilar.
  • Common adverse events in adalimumab clinical trials included infections, injection site reactions, headache, and rash.