(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
(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)—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…
Infliximab Biosimilar Cross Reacts to Infliximab Antibodies; Plus Treat-to-Target Strategy Promising for Treating RA with bDMARDs
In a recent study, 100% of patients with rheumatoid arthritis (RA) on infliximab experienced a cross-reaction when switched to its biosimilar (CT-P13, infliximab-dyyb). Plus in a recent study, a treat-to-target strategy proved effective for treating RA with biological disease-modifying anti-rheumatic drugs…
Biosimilars: Unanswered Questions
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
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…
Adalimumab & Infliximab Remain in Newborns after Delivery
A recent study showed that, when administered during pregnancy, infliximab takes longer to clear an infant’s system than adalimumab…
Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis
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
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,…
Samsung Bioepis Receives Final European Approval for Its Remicade Copy
SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar…
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