Hospira Inc a global leader in biosimilars, today 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.
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.1 Patient symptoms and disease activity were similar before and after the switch between the two treatments, and no immediate safety signals were observed.
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.
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.3 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.
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.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.
