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…
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),…
A recent Phase 3 clinical trial found apremilast safe and effective for treating patients with active psoriatic arthritis and skin symptoms who found conventional and biologic DMARDs ineffective…
Recently, an FDA committee announced support for the approval of CT-P13, an infliximab biosimilar. The FDA has also fast tracked the development of a fibromyalgia treatment designed for multiple symptoms…
Biosimilars Receive Positive News 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 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….
A recent study used MRI to show that tofacitinib reduces inflammation and inhibition of the progression of structural damage in adults with early RA…
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…
An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
NEW YORK (Reuters Health)—In rheumatoid arthritis (RA) patients with an inadequate response to methotrexate, adding tocilizumab to the regimen is more effective than simply switching to tocilizumab, according to Japanese researchers. Dr. Tsutomu Takeuchi told Reuters Health by email that the approach “more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical…