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),…
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….
In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…
In multiple clinical studies, investigational biosimilars for etanercept were shown to be safe and effective for treating rheumatoid arthritis and moderate to severe plaque psoriasis…
Comparing tacrolimus, mycophenolate mofetil and cyclophosphamide, tacrolimus was the most efficacious. Also, biosimilars may soon be easier to differentiate…
The FDA has fast-tracked the development of a drug to treat systemic sclerosis, or scleroderma; initial clinical trials started in June. Also, a major hospital group in France has selected the biosimilar infliximab to treat its patients with RA, Crohn’s disease and psoriasis…
In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…
Biosimilars for etanercept and sarilumab are being examined in multiple Phase 3 trials for their effects in RA and psoriasis patients.
With the U.S. FDA’s first approval of a biosimilar drug earlier this month, rheumatologists stress the need to ensure safety, efficacy of such drugs in treating rheumatic diseases
Ustekinumab-stba (Steqeyma) now has FDA approval for all forms and dosages of its reference product, ustekinumab (Stelara), including a subcutaneous injection to treat pediatric patients with plaque psoriasis or psoriatic arthritis.