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
Celltrionlogo 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.
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