Opportunities and challenges will continue to face the rheumatology community in 2017. In response to these challenges, the ACR has outlined its federal– and state-level legislative and regulatory healthcare priorities for the year. Howard Blumstein, MD, chair of the ACR Affiliate Society Council, says that achieving at least some of these priorities at the state…
Search results for: biosimilars
Potential Benefits, Pitfalls of Biosimilars Reviewed at EULAR 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…
The ACR’s Advocacy at State Legislature Level in 2016 Focuses on Biosimilars, Step Therapy
A majority of state legislatures have concluded their work for 2016. The ACR’s state advocacy efforts continued to focus on policy benefiting rheumatologists and patients alike. The two dominant issues this year were biosimilar substitution and step therapy. Biosimilar Substitution Biosimilar substitution remains the most prevalent issue throughout the states. The ACR continues to monitor…
Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting
In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…
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….
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…
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),…
Rheumatology Drug Updates: Biosimilars Receive Positive News & More
On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 On Jan. 16, 2016, EMA granted marketing authorization in the European Union for Benepali to be used to treat rheumatoid arthritis (RA), psoriatic…
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…
From the Expert: Patient Access Is Key for Biosimilars in Development to Be Effective
Recent research by Michael Weinblatt, MD, and colleagues has demonstrated that a biosimilar derived from adalimumab is both effective and safe for treating patients with rheumatoid arthritis. But Dr. Weinblatt says, the benefits of such biosimilars hinge on cost and patient access…
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