Celltrion’s Inflectra, a Biosimilar to Treat Ulcerative Colitis and Crohn’s Disease, Gets FDA Approval

Celltrion’s Inflectra, a Biosimilar to Treat Ulcerative Colitis and Crohn’s Disease, Gets FDA Approval
 Celltrion recently announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of its Inflectra (biosimilar infliximab) product for all indications of the reference product, Janssen Biotech Inc.'s Remicade (infliximab), originally licensed in 1998. Inflectra is sold in Europe as Remsima. Inflectra is the first biosimilar monoclonal antibody (mAb) medication and second biosimilar overall to receive FDA approval. Inflectra is indicated for the treatment of patients with a range of serious autoimmune diseases. Administered by intravenous infusion, Inflectra is approved for prescription by healthcare professionals for treating: • Adult patients and pediatric patients (ages 6 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; • Adult patients with chronic severe plaque psoriasis. "Biosimilars can provide access to important treatment options for patients who need them," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "Patients and the health care community can be confident that biosimilar products are high quality and meet the agency's rigorous scientific standards." The FDA notes that biological products are generally derived from living organisms, and can derive from many sources, including humans, animals, microorganisms, or yeast. The
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