One of the other areas in which biosimilars are attracting attention is rheumatology and an example of new products coming online was highlighted at the recent Annual European Congress of Rheumatology in London.
Data demonstrating long-term efficacy, safety and immunogenicity for Benepali® (etanercept) and Flixabi® (infliximab) were presented to delegates by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen. Results of studies showed that in patients who were switched to Benepali there were no treatment, safety or immunogenicity issues and efficacy was sustained for up to two years. It was a similar picture with Flixabi. Both were both approved by the European Commission earlier this year and are commercialised in Europe by Biogen.
Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen, said: “Biosimilars can help more patients gain access and benefit from biologic therapies, while providing cost savings to healthcare systems and supporting future healthcare innovation.”
Professor John Isaacs, Director of the Institute of Cellular Medicine at Newcastle University and consultant rheumatologist at the Freeman Hospital, said: “The integration of biosimilars in routine clinical practice is a crucial step to help patients’ access disease-modifying biologic therapies from which they can significantly benefit. “Patient safety is of the utmost importance, and we are beginning to see a solid bank of data that, together with real-world evidence, will further establish the role of biosimilars.”
Among those organisations offering a view on the increasing use of biosimilars is the British Society for Rheumatology, which supports the BSRBR Rheumatoid Arthritis Register run by the Arthritis Research UK Epidemiology Unit at the University of Manchester. The register tracks the progress of patients with severe rheumatoid arthritis, who are receiving biologic agents, to help monitor the safety and effectiveness of the treatments.
A spokesman said: “We strongly recommend that all patients starting or switching to biosimilars should be registered with the BSRBR to allow the capture of the same robust systematic data on adverse effects that have been collected for the reference medicines. The data will ultimately allow clinicians and patients to make informed choices about treatment options.”