FDA approves biosimilar Inflectra — 4 highlights

The FDA has approved the second U.S. biosimilar, Inflectra, according to Gastroenterology & Endoscopy News.

Here are four highlights:

Inflectra is administered by IV infusion and is indicated for:

  • Adults and children (aged six years and older) with moderate to severe Crohn’s disease who have had an inadequate response to conventional therapy
  • Adults with moderate to severe ulcerative colitis who have had an inadequate response to conventional therapy
  • Patients with moderate to severe rheumatoid arthritis, in combination with methotrexate
  • Patients with active ankylosing spondylitis
  • Patients with active psoriatic arthritis
  • Adults with chronic severe plaque psoriasis

2. The FDA approval was based on the comprehensive data package submitted by Celltrion, a biopharmaceutical company based in Incheon, South Korea, demonstrating a high degree of similarity between Inflectra and the U.S. reference product, Remicade.

3. The most common expected side effects of Inflectra include respiratory infections, such as sinus infections and sore throat, headache, coughing and stomach pain.

4. Remicade received FDA approval in 1998.

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