Second Biosimilar Drug in U.S. Is Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Celltrion’s Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson’s Remicade drug used to treat autoimmune diseases. Inflectra is approved to treat adult and pediatric patients (ages 6 years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis (arthritis of the spine); patients with active psoriatic arthritis; and adult patients with chronic severe plaque psoriasis. Respiratory infections, including sinus infections and sore throat, headache, coughing and stomach pain, are the most common expected side effects of the drug.

FDA approval was based on a demonstrated high degree of similarity between Inflectra and Remicade. Pfizer holds the exclusive commercialization rights to Inflectra in the U.S. It is the second biosimilar approved for sale in the U.S.