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Amjevita News

Amjevita OK'd to Treat Inflammatory Diseases

Posted 27 Sep 2016 by Drugs.com

MONDAY, Sept. 26, 2016 – Amjevita (adalimumab-atto) – a biosimilar drug similar to the popular anti-inflammatory drug Humira – has been approved by the U.S. Food and Drug Administration. Amjevita has been approved for moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis (an arthritis that affects the spine); Crohn's disease; ulcerative colitis; plaque psoriasis and juvenile idiopathic arthritis, the FDA said in a news release. Biological drugs are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast, the FDA said. A biosimilar drug is a biological product that's sanctioned after its maker proves it is "highly similar" to an already-approved biologic drug. The manufacturer of the biosimilar drug must prove that the product has "no clinically meaningful differences" in safety, purity ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Plaque Psoriasis, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Adalimumab, Amjevita

FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Posted 26 Sep 2016 by Drugs.com

September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis. Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. “This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new fr ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Maintenance, Adalimumab, Amjevita

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

Amjevita Patient Information at Drugs.com