Inflectra (infliximab-dyyb), which is a biosimilar of Remicade, recently earned approval from officials and leaders with the U.S. Food and Drug Administration (FDA).
Inflectra is the second biosimilar the FDA has approved. It is now approved for prescription from health care professionals through intravenous infusion.
The infusions are designed to treat adult as well as pediatric patients six years old and above who have moderate to severe Crohn’s disease. Other qualifying patients include adult patients who have moderate to severe ulcerative colitis and patients with moderate to severe rheumatoid arthritis, psoriatic arthritis, active ankylosing spondylitis (arthritis of the spine) and chronic severe plaque psoriasis. All of the patients must have shown an inadequate response to traditional therapies in order to qualify for Inflectra.
Biological products are developed from living organisms, such as animals, humans, yeast or microorganisms. To be biosimilar, the biological product must receive approval from its similarity to another biological product that has already been approved (called a reference product).
“Biosimilars can provide access to important treatment options for patients who need them,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said. “Patients and the health care community can be confident that biosimilar products are high-quality and meet the agency’s rigorous scientific standards.”
