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Biologics/DMARDs

Potential Benefits, Pitfalls of Biosimilars Reviewed at EULAR 2016

Thomas R. Collins  |  September 8, 2016

LONDON—The availability of a bio­similar form of infliximab has dramatically increased the number of Norwegians taking one form or another of the drug, an expert on biosimilars said in a debate-style session at the Annual Congress of the European League Against Rheumatism (EULAR 2016). The expanded uptake of Remicade (infliximab) and its biosimilar, Remsima (international…

Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

Kimberly Retzlaff  |  September 8, 2016

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…

Understanding Prescription Pathways for Biologic Medication Therapy

Andrew Hochradel, PharmD, & the ARHP Practice Committee  |  September 8, 2016

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…

FDA Approves Etanercept-szzs Biosimilar

Michele B. Kaufman, PharmD, BCGP  |  September 2, 2016

Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…

What Do Patients Know about Biosimilar Drugs?

Lisa Rapaport, Reuters Staff  |  September 1, 2016

(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…

Novartis Bid to Sell New Biosimilar Crimped by U.S. Court Battles

John Miller  |  September 1, 2016

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…

U.S. FDA Approves Biosimilar to Etanercept

Reuters Staff  |  August 30, 2016

(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…

Adalimumab Lowers Risk of Uveitic Flare

Will Boggs, MD  |  August 30, 2016

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…

FDA Approves Updated Labeling on Risk of Osteonecrosis of the Jaw for Denosumab

Michele B. Kaufman, PharmD, BCGP  |  August 24, 2016

Denosumab’s labeling now says a patient’s risk of developing osteonecrosis of the jaw may increase with prolonged exposure…

FDA Update: Committees Recommend Approvals for Abuse-Deterrent Opioid & Brodalumab

Michele B. Kaufman, PharmD, BCGP  |  August 17, 2016

FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…

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