Hospira, Inc., a global leader in biosimilars, has announced the results of an independent clinical study, showing patients with rheumatic diseases experienced comparable clinical effectiveness and safety after switching from Remicade™ to Inflectra. The study entitled, "Clinical experience with infliximab biosimilar - switch from Remicade. Abstract SAT0174", supports the use of Inflectra, the first biosimilar monoclonal antibody approved in the EU, as a treatment option for people suffering from inflammatory conditions such as rheumatoid arthritis, who are currently receiving stable treatment with reference infliximab.i
The data, presented at the European League Against Rheumatism Annual Congress (EULAR 2015), compared outcomes in 39 patients after a mean of four years of treatment with Remicade, with the outcomes of those same patients after a median of 11 months following a switch to Inflectra.i Patient symptoms and disease activity were similar before and after the switch between the two treatments, and no immediate safety signals were observed.i
"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."
In addition, the results of a meta-analysis of 14 randomised controlled trials assessing safety incidences in 1,454 patients were announced at EULAR. The abstract is titled, "Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. Abstract AB0433." This analysis compared the safety profile of Inflectra from clinical trials in RA and AS, with historical safety data from Remicade clinical trials. The results revealed no meaningful differences in safety (infections, serious infections, malignancies/lymphoma, infusion-related reactions) between patients treated with Inflectra and Remicade.ii
"The study presented at EULAR today provides assurance that switching to Inflectra is a viable, effective treatment alternative to maintenance with Remicade," said Dr. Paul Audhya, Vice President, Medical Affairs, Europe, Middle East and Africa, Hospira.
It has been estimated that 40 percent of RA patients in Europe have severely restricted access to biologics due to the high cost of treatment, with large variations in patient access levels seen across Europe.iii The potential cost savings from biosimilars for healthcare systems could improve patient access to these life-changing medications. A recent study looked at the estimated savings expected from switching RA patients from Remicade to biosimilar infliximab in six countries in Central and Eastern Europe. The study showed that 1,200-1,800 additional RA patients could be treated over a three-year period if the savings of between €15.3-20.8M were spent on reimbursement of additional biosimilar infliximab treatment.iv
"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.
Inflectra received its authorization from the European Commission (EC) in September 2013 for all the licensed indications of Remicade, which has been authorized in the EU since 1999 and recorded European sales of almost €2 billion in 2013.v Inflectra is now available in 26 European countries, launching in 13 new markets earlier this year, following the patent expiry of Remicade. Inflectra is also available in Canada, has recently been approved by the regulatory authority, ANVISA, in Brazil and has been submitted to the U.S. Food and Drug Administration (FDA) for approval.