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Biologics/DMARDs

Samsung Bioepis Receives Final European Approval for Its Remicade Copy

Reuters Staff  |  

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…

TNF Blocking Drugs Persist in Infants after Exposure In-Utero

Anne Harding  |  

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 Drug Updates: Infliximab Biosimilar Gets FDA Approval & More

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April 5, 2016, marks a revolutionary day in the treatment of autoimmune diseases: The U.S. Food and Drug Administration (FDA) approved an infliximab (Remicade) biosimilar, known as Inflectra (infliximab-dyyb). Infliximab-dyyb, which is administered by intravenous infusion, is the first biosimilar drug approved to treat rheumatic disease in the U.S.1 Infliximab-dyyb has received approval for almost…

Biosimilars: Expanded Treatment Options

Joan M. Von Feldt, MD, MSEd, FACR, FACP  |  

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…

Golimumab Effective as Maintenance Treatment for Active Ulcerative Colitis

Will Boggs, MD  |  

NEW YORK (Reuters Health)—Subcutaneous golimumab every four weeks provides effective long-term maintenance for patients with active ulcerative colitis (UC), according to results from the PURSUIT-SC extension study. The main PURSUIT-M study showed that golimumab treatment maintained clinical responses through Week 54. For most patients, maintenance therapy for UC is required long term. Dr. Peter R….

Tofacitinib Promising for Psoriatic Arthritis & FDA Issues Alert for Warning for Saxagliptin & Alogliptin Diabetes Treatments

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A recent Phase 3 study found tofacitinib safe and effective for treating psoriatic arthritis at both 5 mg and 10 mg doses compared with placebo. And the FDA has added label warnings to saxagliptin and alogliptin for an increased risk of heart failure in individuals taking the drugs, particularly in those with heart and kidney disease…

Mucosal Healing Seen with Infliximab Biosimilar CT-P13 in Ulcerative Colitis

Reuters Staff  |  

NEW YORK (Reuters Health)—About two-thirds of patients with ulcerative colitis (UC) had mucosal healing by the end of induction treatment with the infliximab biosimilar CT-P13, according to results of the first prospective study to evaluate this. CT-P13 is the first biosimilar monoclonal antibody of reference infliximab (Remicade) approved in Europe and several other countries where…

Ustekinumab Improves Spondylitis in Patients with Psoriatic Arthritis

Will Boggs, MD  |  

NEW YORK (Reuters Health)—The anti-interleukin (IL)-12/IL-23 monoclonal antibody ustekinumab improves signs and symptoms of spondylitis in patients with psoriatic arthritis, according to a post-hoc analysis of data from the PSUMMIT-1 and PSUMMIT-2 trials. “This treatment did seem to have a benefit on axial symptoms,” Dr. Arthur Kavanaugh from the University of California San Diego, La…