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Biologics/DMARDs

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff  |  

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke  |  

(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…

FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira

Reuters Staff  |  

(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…

Biosimilars: Unanswered Questions

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Debate continues about how biosimilars that are emerging to treat rheumatic diseases will be named and monitored, said panelists at a recent meeting in Washington, D.C.—Biosimilars in the United States: Next Steps. Angus Worthing, MD, FACR, FACP, a member of the ACR’s Government Affairs Committee, shared rheumatologists’ concerns as these new therapies come to market….

Arthritis Patients Lack Knowledge about Safe Use of Biologics

Will Boggs, MD  |  

NEW YORK (Reuters Health)—Many patients with arthritis lack the knowledge to use their biologic treatments safely, researchers from France report. “Some patients are at risk of poorly managing their biologic therapy, especially patients living alone, in a large city, patients with low education level, or (patients who are) unemployed,” Dr. Anne-Christine Rat from CHU de…

Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis

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Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…

Adalimumab Drives Regulatory T Cell Expansion by Binding to Membrane TNF

Will Boggs, MD  |  

NEW YORK (Reuters Health)—The anti-tumor necrosis factor (TNF) antibody adalimumab drives regulatory T cell (Treg) expansion in rheumatoid arthritis (RA) by binding to membrane TNF, researchers from the UK report. “These results show that adalimumab enhances the anti-inflammatory actions of TNF to increase regulatory T cell activity,” Dr. Michael R. Ehrenstein from University College London,…