NEW YORK (Reuters Health)—Biosimilar tumor necrosis factor-alpha inhibitors appear equivalent to the branded original versions, according to a systematic review and meta-analysis. As Dr. G. Caleb Alexander tells Reuters Health by email, “biologic treatments represent a rapidly growing proportion of prescription drug expenditures and thus there is enormous interest in whether or not biosimilar products…
Search results for: infliximab
U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…
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….
The Gut Microbiome Influences Postmenopausal Bone Loss
Bone health has been successfully improved by using probiotics to influence the gut microbiome in postmenopausal women with osteoporosis. New research has gained insight into this process, uncovering that sex steroid depletion increases gut permeability resulting in inflammation and pathology in mice. Treatment with probiotics also prevents this increase in gut permeability and bone loss associated with sex steroid depletion…
Rheumatoid Arthritis & Autoimmune Glomerulonephritis
Rheumatoid arthritis (RA) is rarely associated with renal manifestations, but secondary amyloidosis due to chronic inflammation is reported to be the etiology of renal dysfunction in many cases of RA.1,2 The discovery of biologic therapy, with TNF-alpha inhibitors in particular, made a huge difference in the disease course and prognosis of RA patients. However, TNF-alpha…
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…
Roche & Novartis Face Off in Biosimilar Drug Battle
ZURICH (Reuters)—Switzerland’s biggest drugmakers are clashing over cheaper copies of pricey biotech drugs—one reason why Novartis is considering selling its $14 billion stake in cross-town rival Roche. With a copycat of Roche’s blood cancer drug Rituxan (rituximab) pending European approval, Novartis aims to muscle in on a share of sales that last year hit 7…
TNF Blocking Drugs Persist in Infants after Exposure In-Utero
NEW YORK (Reuters Health)—Babies born to mothers who took anti-tumor necrosis factor (anti-TNF) agents during pregnancy have detectable drug in their bodies up to 12 months of age, new findings show. These infants should therefore not receive live vaccines during their first year of life, Dr. Mette Julsgaard of Aarhus University Hospital in Denmark and…
Rheumatology Coding Corner Question: Documentation Improvement
A 55-year-old female patient returns for her second infliximab infusion. Her temperature is 98°F, her height is 5’6″ and her weight is 151 lbs. She received 210 mg infliximab via infusion. The patient arrived at the clinic at 8:15 a.m. and left at 10:55 a.m. Can this encounter be coded correctly? Yes No A 38-year-old…
Biosimilars: Expanded Treatment Options
Soon, biosimilars will be available as treatment options for our patients. Biosimilars are being introduced to the U.S. market in the hope that they will spur competition and drive down the price of these expensive medicines. Previous articles in The Rheumatologist have touched on various issues surrounding these new therapies, and everyone in the rheumatology…
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