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Inflectra News

Inflectra Approved as 'Biosimilar' to Remicade

Posted 7 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – The U.S. Food and Drug Administration has approved its second-ever "biosimilar" drug, Inflectra, for adults with Crohn's disease, rheumatoid arthritis or chronic plaque psoriasis, among other prescribed uses. In a media release, the agency said Inflectra was biosimilar to Janssen Biotech's Remicade (infliximab), first licensed in 1998. A biosimilar drug is sanctioned based on its maker's ability to show that it is "highly similar" to an already-approved biological drug that is generally derived from a living organism, such as a person, animal, microorganism or yeast, the FDA said. The maker of a biosimilar drug also must prove that the product has no "clinically meaningful difference" in safety and effectiveness from the original drug, and that the newer product has only "minor differences in clinically inactive components" from the original. Inflectra's most ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Remicade, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Plaque Psoriasis, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Inflectra

FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade

Posted 7 Apr 2016 by Drugs.com

April 5, 2016 – The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of: adult patients and pediatric patients (ages six 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 ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Remicade, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Plaque Psoriasis, Infliximab, Inflectra

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Related Condition Support Groups

Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Crohn's Disease - Maintenance, Psoriasis

Inflectra Patient Information at Drugs.com