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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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…
Triple Therapy with Methotrexate Effective, Cheaper in RA
NEW YORK (Reuters Health)—The combination of methotrexate, sulphasalazine and hydroxychloroquine is similar in effect as methotrexate plus biologic therapy for patients with rheumatoid arthritis (RA), according to a new network meta-analysis. “Thus, for most patients, this low-cost combination of medications should probably be tried before moving onto biologic therapy, either as initial treatment or as…
Biosimilars Debate Heats up over Cost Savings, Safety Concerns
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
Hidradenitis Suppurativa Can Complicate Biologic Therapy
NEW YORK (Reuters Health)—Hidradenitis suppurativa can complicate biologic therapy of chronic inflammatory diseases, according to a retrospective study from France and Belgium. Hidradenitis suppurativa (HS) often responds to treatment with biologic agents, but there have been scattered reports of patients developing HS while undergoing biologic therapy. Dr. Coline Faivre from Hôpital Edouard Herriot in Lyon,…
Remicade Antibodies Cross-React to Biosimilars
NEW YORK (Reuters Health)—Patients with antibodies to infliximab in Remicade should not be switched to biosimilars, researchers warn. “(The) antibodies will cross-react with the new biosimilar drug, potentially reducing clinical response,” Dr. Daniel Nagore, director of research and development at Progenika Biopharma in Derio, Spain, told Reuters Health by email. “The study highlights the importance…
FDA Approves Biosimilar to J&J’s Remicade for Multiple Diseases
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade (infliximab), to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Inflectra, also known as infliximab-dyyb, is expected by some analysts to sell for a 25% discount to Remicade, which generated annual…
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