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…
In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…
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….
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…
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),…
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…
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…
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…
The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…
Tofacitinib has been released from the FDA’s risk evaluation and mitigation strategy requirement. The FDA is also reviewing a biologics license application for ABP-501, an adalimumab biosimilar. And CHS-0214, a proposed etanercept biosimilar, has met its primary endpoint at Week 24 in an ongoing 52-week study…