Clinical value beyond price alone: biosimilars improve patient access to treatment
Immune-mediated inflammatory diseases (IMID) are a group of chronic conditions characterised by altered immune regulation causing chronic inflammation in targeted organs or systems.
IMIDs affect approximately 3–7% of the global population, with an estimated incidence of 80 per 105 person-years1,2.
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- Cooper GS SB. The epidemiology of autoimmune diseases. Autoimmun Rev. 2003;2(3):119–125.
- El-Gabalawy H, Guenther LC BC. Epidemiology of immune-mediated inflammatory diseases: incidence, prevalence, natural history, and comorbidities. J Rheumatol Suppl. 2010;85:2–10.
- Williams JP MJ. Immune-mediated inflammatory disorders (I.M.I.D.s): the economic and clinical costs. JA Am J Manag Care. 2002;8(21):S664-681.
- Kuek A, Hazleman BL ÖA. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgr med J. 2007;83(978):251–260.
- Burisch J, Jess T, Martinato M, Lakatos PL E, E. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013;7(4):322–337.
- Griffiths CE, Jo SJ, Naldi L, Romiti R, Guevara‐Sangines E, Howe T et al. A multidimensional assessment of the burden of psoriasis: results from a multinational dermatologist and patient survey. Br J Dermatol. 2018;179(1):173–181.
- Anaya JM, Gómez L CJ. Is there a common genetic basis for autoimmune diseases? Clin Dev Immunol. 2006;13(1):185–195.
- Cote-Daigneault J, Bouin M, Lahaie R CJ, P. P. Biologics in inflammatory bowel disease: what are the data? United Eur Gastroenterol J. 2015;3(5):419–428.
- Rein P MR. Treatment with biologicals in rheumatoid arthritis: an overview. Rheumatol Ther. 2017;4(2):247–261.
- Ronholt K IL. Old and new biological therapies for psoriasis. Int J Mol Sci. 2017;18:2297.
- Law ST TP. Role of biological agents in treatment of rheumatoid arthritis. Pharmacol Res. 2019;150:104497.
- Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340(4):253–259.
- Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med. 1999;130(6):478–486.
- Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG et al. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1):106–115.
- Strand V SJ. Newer biological agents in rheumatoid arthritis: impact on health-related quality of life and productivity. Drugs. 2010;70(2):121–145.
- LeBlanc K, Mosli MH, Parker CE MJ. The impact of biological interventions for ulcerative colitis on health-related quality of life. Cochrane Database Syst Rev. 2015;CD008655.
- Nurmohamed M, Choy E, Lula S, Kola B DR, P. A. The impact of biologics and tofacitinib on cardiovascular risk factors and outcomes in patients with rheumatic disease: a systematic literature review. Drug Saf. 2018;41(5):473–488.
- Ward MM, Deodhar A, Gensler LS, Dubreuil M, Yu D, Khan MA et al. 2019 Update of the American College of Rheumatology/ Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599–1613.
- Rubin DT, Ananthakrishnan AN, Siegel CA S, BG LM. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114(3):384–413.
- Smolen JS, Landewé RB, Bijlsma JW, Burmester GR, Dougados M, Kerschbaumer A et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685–699.
- Torres J, Bonovas S, Doherty G, Kucharzik T, Gisbert JP, Raine T et al. ECCO guidelines on therapeutics in Crohn’s disease: medical treatment. J Crohns Colitis. 2020;14(1):4–22.
- Pillai N, Dusheiko M, Burnand B P V. A systematic review of cost-effectiveness studies comparing conventional, biological and surgical interventions for inflammatory bowel disease. PLoS One. 2017;12(10):e0185500.
- IQVIA. Global, European and Belgian pharmaceutical market trends. 2019.
- S. G. Don’t give up on biosimilars - congress can give them a boost: drugs grown in live cells are hard to replicate. But policy changes can help accelerate the process. Am Heal Drug Benefits. 2019;12(5):252–253.
- Bergstra SA, Branco JC, Vega-Morales D, Salomon-Escoto K, Govind N, Allaart CF et al. Inequity in access to bDMARD care and how it influences disease outcomes across countries worldwide: results from the METEOR-registry. Ann Rheum Dis. 2018;77(10):1413–1420.
- Baumgart DC, Misery L, Naeyaert S TP. Biological therapies in immune-mediated inflammatory diseases: can biosimilars reduce access inequities? Front Pharmacol. 2019;10:279.
- Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014;73(1):198–206.
- Kaló Z, Vokó Z, Östör A, Clifton-Brown E, Vasilescu R, Battersby A et al. Patient access to reimbursed biological disease-modifying antirheumatic drugs in the European region. J Mark Access Heal Policy. 2017;5(1):1345580.
- Kawalec P, Stawowczyk E, Tesar T, Skoupa J, Turcu-Stiolica A, Dimitrova M. Pricing and reimbursement of biosimilars in central and Eastern European countries. Front Pharmacol. 2017;8:288.
- Rezk MF PB. Unlocking the Value of Anti-TNF Biosimilars: Reducing Disease Burden and Improving Outcomes in Chronic Immune-Mediated Inflammatory Diseases: A Narrative Review. Adv Ther. 2020;37:3732–3745.
- Inotai A, Csanadi M, Petrova G, Dimitrova M, Bochenek T, Tesar T et al. Patient access, unmet medical need, expected benefits, and concerns related to the utilisation of biosimilars in Eastern European countries: a survey of experts. Biomed Res Int. 2018;2018:9597362.
- World Health Organization. Expert Committee on Biological Standardization. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. www.who.int/biologicals/areas/biological therapeutics/BIOTHERAPEUTICS FOR WEB 22APRIL2010.pdf.
- Dutta B, Huys I, Vulto AG SS. Identifying key benefits in European off-patent biologics and biosimilar markets: it is not only about price! Bio- Drugs. 2020;34(2):159–170.
- Uhlig T GG. Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatol (Oxford). 2017;56(4):iv49–62.
- Simoens S VA. A health economic guide to market access of biosimilars. Expert Opin Biol Ther. 2021;21(1):9–17.
- Matusewicz W, Godman B, Pedersen HB, Fürst J, Gulbinovič J, Mack A, Selke G et al. Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe. Expert Rev Pharmacoecon Outcomes Res. 2015;15:755–758.
- IMS Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines. 2016. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf. Accessed 24 February 2021.
- Tinsley SM, Grande C, Olson K, Plato L JI. Potential of biosimilars to increase access to biologics: considerations for advanced practice providers in oncology. J Adv Pr Oncol. 2018;9(7):699.
- Zielinska J BW. Recent changes on the biopharmaceutical market after the introduction of biosimilar G-CSF products. Oncol Clin Pr. 2016;12:144–152.
- Gascón P, Tesch H, Verpoort K, Rosati MS, Salesi N, Agrawal S et al. Clinical experience with Zarzio in Europe: what have we learned? Support Care Cancer. 2012;21(10):2925–2932.
- Atsumi T, Tanaka Y, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N et al. Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial. Ann Rheum Dis. 2017;76(8):1348–1356.
- Colombel JF, Panaccione R, Bossuyt P, Lukas M, Baert F, Vaňásek T et al. Effect of tight control management on Crohn’s disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2018;390(10114):2779–2789.
- Mao EJ, Hazlewood GS, Kaplan GG, Peyrin-Biroulet L AAN. Mao, E. J., Hazlewood, G. S., Kaplan, G. G., Peyrin-Biroulet, L., and Ananthakrishnan, A. N. (2017). Systematic review with meta-analysis: comparative efficacy of immunosuppressants and biologics for reducing hospitalisation and surgery in Crohn’s disease. Aliment Pharmacol Ther. 2017;45:3–13.
- Wook Hong S, Kim YG YB. An updated review of infliximab biosimilar, CT-P13, in the treatment of immune-mediated inflammatory diseases. Immunotherapy. 2020;12(9):609–623.
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Biosimilars are uniquely placed to change clinical practice in the fields of gastroenterology, rheumatology, and dermatology. The adoption of biosimilars can improve patient access to the most appropriate treatment, at the optimum time, to ensure the best possible long-term disease outcomes.
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