U.S. License Holder:
Samsung Bioepsis Co. Ltd.
Date of License:
April-21-2017
Last Update:
Dec-15-2024
FDA-Approved Indications
RENFLEXIS (infliximab-abda) is a tumor necrosis factor (TNF) blocker indicated for:
Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy; reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease;
Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy;
Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy;
Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy;
Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease;
Ankylosing Spondylitis: reducing signs and symptoms in adult patients with active disease;
Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients;
Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Renflexis (infliximab) (Samsung Bioepis) (March-2018)
Biosimilars Approved In The E.U.
Flixabi (Samsung Bioepsis) (May-2016)
Biosimilars Approved In Australia
Renflexis (Samsung Bioepis / Merck) (November-2016)
Biosimilars Approved In South Korea
Remaloce (Samsung Bioepis / Merck) (December-2015)
U.S. Patent Litigations
