The use of biosimilars for rheumatology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…
Executing evidence-based medicine in the U.S. is challenging, especially utilizing high-cost medications in rheumatologic care. As patients trust their clinicians to be their medical experts, clinicians must trust their care team members to be experts at implementing the care plan. A clinician’s knowledge of human anatomy and physiology is the foundation to understanding pathophysiology. From…
Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…
(Reuters Health)—Many patients haven’t heard of biosimilars, generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests.1 To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease…
ZURICH (Reuters)—Novartis has won U.S. approval for a copy of Amgen’s blockbuster arthritis drug Enbrel, but the Swiss drugmaker’s bid to muscle in on the medicine’s $4.7 billion in annual U.S. revenue remains blocked by court battles. Novartis’s Sandoz unit said on Tuesday the U.S. Food and Drug Administration (FDA) approved Erelzi, its biosimilar copy…
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no…
NEW YORK (Reuters Health)—Adalimumab reduces the risk of uveitic flare after corticosteroid withdrawal in patients with inactive, noninfectious uveitis, according to results from VISUAL II. “Tumor-necrosis factor (TNF) inhibition, which has been demonstrated to have strong efficacy in rheumatologic disorders, can also have significant role in the management of noninfectious uveitis, even amidst the challenges…
Denosumab’s labeling now says a patient’s risk of developing osteonecrosis of the jaw may increase with prolonged exposure…
FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…
Cross Reactions A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to…