Renflexis, a Remicade Biosimilar, Launched in US to Treat Crohn’s and UC

Renflexis, a Remicade Biosimilar, Launched in US to Treat Crohn’s and UC
New drug Renflexis (infliximab-abda), a therapy for ulcerative colitis and Crohn’s disease, is being launched in the U.S., South Korea’s Samsung Bioepis recently announced. Renflexis is a biosimilar of the anti-inflammatory drug Remicade (infliximab) and is being commercialized in the U.S. by Merck. Biosimilars are therapies with no clinically relevant differences to a biological reference product previously approved by the U.S. Food and Drug Administration (FDA). They present almost identical structure and activity to the reference product, and can be produced when the original product’s patent expires. Renflexis was approved by the FDA in April 2017 as an injectable 100 mg dose to treat a number of autoimmune diseases (where the body’s immune system attacks healthy cells), including ulcerative colitis and Crohn’s disease. Renflexis may also be used by people with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. For Crohn’s disease and ulcerative colitis, Renflexis is indicated to reduce signs and symptoms and achieve stable clinical remission in adult patients with moderate to severe disease who do not show successful response to conventional therapy. Renflexis taken for ulcerative colitis also aims to maintain mucosal healing (a measure of clinical activity) and eliminate corticosteroid use. Renflexis is also recommended for pediatri
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3 comments

  1. Donna Ellis says:

    Wish the FDA would approve fecal transplants for ulcerative colitis. Guess there is less of a money gain in that approach. I’m staying hopeful. It’s the way to help sufferers.

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