Hospira, Inc. a world leading company in biosimilars, recently announced its data from an independent study in which patients with rheumatic diseases had similar safety and clinical effectiveness after switching from Remicade to Inflectra.
Results from the study entitled, “Clinical experience with infliximab biosimilar – switch from Remicade.Abstract SAT0174,” further support the use of Inflectra, a novel biosimilar monoclonal antibody that has been approved in the European Union as a treatment for patients with inflammatory disease such as rheumatoid arthritis, who are under treatment with infliximab.
The study was recently presented during the 2015 Annual Meeting of the European League Against Rheumatism (EULAR 2015), reports the clinical outcomes of 39 patients who received treatment with Remicade for about four years, in comparison to the clinical outcomes of the same patients after being treated with Inflectra for about 11 months.
The results show that disease activity and symptomatology were identical prior and after the switch between the two drugs, with no safety issues reported.
“This post-market study shows that patients with various rheumatic conditions who are stable on Remicade treatment don’t experience a loss of effectiveness or unexpected side effects when switched to biosimilar infliximab,” said Dr. Tuulikki Sokka, Head of Rheumatology at Jyväskylä Central Hospital, Finland, and author of the study. “Real world studies such as this can help provide additional confidence in biosimilars, giving clinicians an opportunity to reduce healthcare spending and provide greater access to biologic medicines for patients in need.”
During the EULAR, the company also reported data on a recent meta-analysis titled “Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. Abstract AB0433“ comprising 14 randomised controlled trials that looked at the safety incidences of 1,454 patients. The meta-analysis compared Inflectra’s safety profile in trials with RA and AS patients with results from Remicade trials. The data showed there were no differences in terms of safety between the use of the two drugs.
“The study presented at EULAR today provides assurance that switching to Inflectra is a viable, effective treatment alternative to maintenance with Remicade,” said Paul Audhya, M.D., Vice President, Medical Affairs, Europe, Middle East and Africa, Hospira.
A recent study has also looked at the potential savings from switching RA patients from Remicade to the biosimilar drug infliximab, revealing that 1,200-1,800 additional patients with RA could receive treatment for 3 years if the savings of between €15.3-20.8M were spent on reimbursement of biosimilar infliximab treatment.
“With more and more people living with chronic diseases, such as RA, the strain on our healthcare economy is only going to increase. Hospira is committed to delivering high quality, biosimilar medicines at a lower cost than the reference product, to increase patient access to biologic medicines,” said Paul Greenland, Vice President Biologics, Hospira.
The drug is currently available in 26 European countries, and is also available in Canada, in Brazil, and has been submitted for approval to the U.S. Food and Drug Administration (FDA).