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Drugs
Published in: Drugs 2/2020

Open Access 01-02-2020 | Infliximab | Leading Article

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Authors: HoUng Kim, Rieke Alten, Luisa Avedano, Axel Dignass, Fernando Gomollón, Kay Greveson, Jonas Halfvarson, Peter M. Irving, Jørgen Jahnsen, Péter L. Lakatos, JongHyuk Lee, Souzi Makri, Ben Parker, Laurent Peyrin-Biroulet, Stefan Schreiber, Steven Simoens, Rene Westhovens, Silvio Danese, Ji Hoon Jeong

Published in: Drugs | Issue 2/2020

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Abstract

Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars—biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators—can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.
Appendix
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Literature
1.
2.
Sarzi-Puttini P, Ceribelli A, Marotto D, et al. Systemic rheumatic diseases: from biological agents to small molecules. Autoimmun Rev. 2019;18:583–92.PubMedCrossRef
3.
Ben-Horin S, Vande Casteele N, Schreiber S, et al. Biosimilars in inflammatory bowel disease: facts and fears of extrapolation. Clin Gastroenterol Hepatol. 2016;14:1685–96.PubMedCrossRef
4.
5.
6.
7.
8.
9.
10.
11.
Glintborg B, Sorensen J, Hetland ML. Does a mandatory non-medical switch from originator to biosimilar infliximab lead to increased use of outpatient healthcare resources? A register-based study in patients with inflammatory arthritis. RMD Open. 2018;4:e000710.PubMedPubMedCentralCrossRef
12.
Glintborg B, Sørensen IJ, Loft AG, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017;76:1426.PubMedCrossRef
13.
Glintborg B, Loft AG, Omerovic E, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis 2019;78:192.
14.
Al-Sabbagh A, Olech E, McClellan JE, et al. Development of biosimilars. Semin Arthritis Rheum. 2016;45:S11–8.PubMedCrossRef
15.
Vulto AG and Jaquez OA. The process defines the product: what really matters in biosimilar design and production? Rheumatology (Oxford) 2017;56:iv14–29.
16.
Tsuruta LR, Lopes dos Santos M, and Moro AM. Biosimilars advancements: moving on to the future. Biotechnol Prog 2015;31:1139–49.
17.
Isaacs J, Goncalves J, Strohal R, et al. The biosimilar approval process: how different is it? Consider Med. 2017;1:3–6.CrossRef
18.
19.
20.
21.
Declerck P and Farouk Rezk M. The road from development to approval: Evaluating the body of evidence to confirm biosimilarity. Rheumatology (Oxford) 2017;56:iv4–iv13.
22.
Bui LA, Hurst S, Finch GL, et al. Key considerations in the preclinical development of biosimilars. Drug Discov Today. 2015;20(Suppl 1):3–15.PubMedCrossRef
23.
Weise M, Bielsky M-C, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111–7.PubMedCrossRef
24.
Berkowitz SA, Engen JR, Mazzeo JR, et al. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11:527–40.PubMedPubMedCentralCrossRef
25.
Háda V, Bagdi A, Bihari Z, et al. Recent advancements, challenges, and practical considerations in the mass spectrometry-based analytics of protein biotherapeutics: a viewpoint from the biosimilar industry. J Pharm Biomed Anal. 2018;161:214–38.PubMedCrossRef
26.
27.
28.
29.
Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015;44:S2–8.PubMedCrossRef
30.
Lai Z, La Noce A. Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example. RMD Open. 2016;2:e000154.PubMedPubMedCentralCrossRef
31.
Jairath V, Zou GY, Parker CE, et al. Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis. Cochrane Database Syst Rev 2017;9:Cd011572.
32.
Ma C, Guizzetti L, Panaccione R, et al. Systematic review with meta-analysis: endoscopic and histologic placebo rates in induction and maintenance trials of ulcerative colitis. Aliment Pharmacol Ther. 2018;47:1578–96.PubMedCrossRef
33.
Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613–20.PubMedPubMedCentralCrossRef
34.
Ye BD, Pesegova M, Alexeeva O, et al. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019;393:1699–707.PubMedCrossRef
35.
Meyer A, Rudant J, Drouin J, et al. Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: a French equivalence study. Ann Intern Med. 2019;170:99–107.PubMedCrossRef
36.
Meyer A, Rudant J, Drouin J, et al. The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis. Aliment Pharmacol Ther. 2019;50:269–77.PubMedPubMedCentralCrossRef
37.
Kolar M, Duricova D, Bortlik M, et al. Infliximab biosimilar (Remsima™) in therapy of inflammatory bowel diseases patients: experience from one tertiary inflammatory bowel diseases centre. Dig Dis. 2017;35:91–100.PubMedCrossRef
38.
Farkas K, Rutka M, Balint A, et al. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis—experiences from a single center. Expert Opin Biol Ther. 2015;15:1257–62.PubMedCrossRef
39.
Farkas K, Rutka M, Golovics PA, et al. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. J Crohns Colitis. 2016;10:1273–8.PubMedCrossRef
40.
Balint A, Rutka M, Kolar M, et al. Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis—results from multicenter observational cohort. Expert Opin Biol Ther. 2018;18:1181–7.PubMedCrossRef
41.
Tursi A, Allegretta L, Chiri S, et al. Effectiveness and safety of infliximab biosimilar CT-P13 in treating ulcerative colitis: a real-life experience in IBD primary centers. Minerva Gastroenterol Dietol. 2017;63:313–8.PubMed
42.
43.
Doevendans E, Schellekens H. Immunogenicity of innovative and biosimilar monoclonal antibodies. Antibodies (Basel, Switzerland). 2019;8:21.
44.
Jani M, Dixon WG, Chinoy H. Drug safety and immunogenicity of tumour necrosis factor inhibitors: the story so far. Rheumatology (Oxford). 2018;57:1896–907.CrossRef
45.
46.
47.
Kim JS, Kim SH, Kwon B, et al. Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13). Expert Rev Clin Immunol. 2015;11:33–41.CrossRef
48.
Schreitmüller T, Barton B, Zharkov A, et al. Comparative immunogenicity assessment of biosimilars. Future Oncol. 2019;15:319–29.PubMedCrossRef
49.
Gorovits B, Baltrukonis DJ, Bhattacharya I, et al. Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab. Clin Exp Immunol. 2018;192:348–65.PubMedPubMedCentralCrossRef
50.
Vermeire S, Gils A, Accossato P, et al. Immunogenicity of biologics in inflammatory bowel disease. Therap Adv Gastroenterol 2018;11:1756283x17750355.
51.
Billmeier U, Dieterich W, Neurath MF, et al. Molecular mechanism of action of anti-tumor necrosis factor antibodies in inflammatory bowel diseases. World J Gastroenterol. 2016;22:9300–13.PubMedPubMedCentralCrossRef
52.
53.
Nakken B, Papp G, Bosnes V, et al. Biomarkers for rheumatoid arthritis: from molecular processes to diagnostic applications-current concepts and future perspectives. Immunol Lett. 2017;189:13–8.PubMedCrossRef
54.
Cazap E, Jacobs I, McBride A, et al. Global acceptance of biosimilars: importance of regulatory consistency, education, and trust. Oncologist. 2018;23:1188–98.PubMedPubMedCentralCrossRef
55.
Kirchhoff CF, Wang XM, Conlon HD, et al. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114:2696–705.PubMedPubMedCentralCrossRef
56.
57.
58.
Takeuchi T, Yamanaka H, Tanaka Y, et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2015;25:817–24.PubMedPubMedCentralCrossRef
59.
Tanaka Y, Yamanaka H, Takeuchi T, et al. Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol. 2017;27:237–45.PubMedCrossRef
60.
61.
62.
63.
Calvo B, Martinez-Gorostiaga J, Echevarria E. The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation. Ther Adv Drug Saf. 2018;9:601–8.PubMedPubMedCentralCrossRef
64.
65.
66.
67.
68.
69.
Smolen JS, Landewe R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76:960–77.PubMedCrossRef
70.
Lau CS, Chia F, Harrison A, et al. APLAR rheumatoid arthritis treatment recommendations. Int J Rheum Dis. 2015;18:685–713.PubMedCrossRef
71.
Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2016;68:1–25.CrossRef
72.
73.
Deighton C, Hyrich K, Ding T, et al. BSR and BHPR rheumatoid arthritis guidelines on eligibility criteria for the first biological therapy. Rheumatology (Oxford). 2010;49:1197–9.CrossRef
74.
Cardiel MH, Latin American Rheumatology Associations of the Pan-American League of Associations for R, and Grupo Latinoamericano de Estudio de Artritis R. First Latin American position paper on the pharmacological treatment of rheumatoid arthritis. Rheumatology (Oxford) 2006;45 Suppl 2:ii7–ii22.
75.
Lau CS, Chia F, Dans L, et al. 2018 update of the APLAR recommendations for treatment of rheumatoid arthritis. Int J Rheum Dis. 2019;22:357–75.PubMedCrossRef
76.
77.
Bergstra SA, Branco JC, Vega-Morales D, 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;77:1413.PubMedCrossRef
78.
Gulacsi L, Brodszky V, Baji P, et al. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev Clin Immunol. 2015;11(Suppl 1):S43–52.PubMedCrossRef
79.
Kalo Z, Voko Z, Ostor A, et al. Patient access to reimbursed biological disease-modifying antirheumatic drugs in the European region. J Mark Access Health Policy. 2017;5:1345580.PubMedPubMedCentralCrossRef
80.
Putrik P, Ramiro S, Kvien TK, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014;73:198–206.PubMedCrossRef
81.
Baumgart DC, Misery L, Naeyaert S, et al. Biological therapies in immune-mediated inflammatory diseases: can biosimilars reduce access inequities? Front Pharmacol. 2019;10:279.PubMedPubMedCentralCrossRef
82.
Putrik P, Ramiro S, Kvien TK, et al. Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country’s wealth? Ann Rheum Dis. 2014;73:2010–21.
83.
Conaghan PG, Hensor EMA, Keenan A-M, et al. Persistently moderate DAS-28 is not benign: loss of function occurs in early RA despite step-up DMARD therapy. Rheumatology. 2010;49:1894–9.PubMedCrossRef
84.
Ceccarelli F, Massafra U, Perricone C, et al. Anti-TNF treatment response in rheumatoid arthritis patients with moderate disease activity: a prospective observational multicentre study (MODERATE). Clin Exp Rheumatol. 2017;35:24–32.PubMed
85.
Fan R, Zhong J, Wang ZT, et al. Evaluation of “top-down” treatment of early Crohn’s disease by double balloon enteroscopy. World J Gastroenterol. 2014;20:14479–87.PubMedPubMedCentralCrossRef
86.
Hibi T, Panaccione R, Katafuchi M, et al. The 5C concept and 5S principles in inflammatory bowel disease management. J Crohns Colitis. 2017;11:1302–8.PubMedPubMedCentralCrossRef
87.
Im JP, Ye BD, Kim YS, et al. Changing treatment paradigms for the management of inflammatory bowel disease. Korean J Intern Med. 2018;33:28–35.PubMedCrossRef
88.
Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting therapeutic targets in inflammatory bowel disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol. 2015;110:1324–38.PubMedCrossRef
89.
Vaughn BP, Shah S, Cheifetz AS. The role of mucosal healing in the treatment of patients with inflammatory bowel disease. Curr Treat Opt Gastroenterol. 2014;12:103–17.CrossRef
90.
D’Haens GR, Sartor RB, Silverberg MS, et al. Future directions in inflammatory bowel disease management. J Crohns Colitis. 2014;8:726–34.PubMedCrossRef
91.
Peyrin-Biroulet L, Ferrante M, Magro F, et al. Results from the 2nd Scientific Workshop of the ECCO. I: Impact of mucosal healing on the course of inflammatory bowel disease. J Crohns Colitis 2011;5:477–83.
92.
Ordas I, Feagan BG, Sandborn WJ. Early use of immunosuppressives or TNF antagonists for the treatment of Crohn’s disease: time for a change. Gut. 2011;60:1754–63.PubMedCrossRef
93.
Kang B, Choe YH. Early biologic treatment in pediatric Crohn’s disease: catching the therapeutic window of opportunity in early disease by treat-to-target. Pediatr Gastroenterol Hepatol Nutr. 2018;21:1–11.PubMedPubMedCentralCrossRef
94.
Sandborn WJ, Hanauer S, Van Assche G, et al. Treating beyond symptoms with a view to improving patient outcomes in inflammatory bowel diseases. J Crohns Colitis. 2014;8:927–35.PubMedCrossRef
95.
Tsui JJ, Huynh HQ. Is top-down therapy a more effective alternative to conventional step-up therapy for Crohn’s disease? Ann Gastroenterol. 2018;31:413–24.PubMedPubMedCentral
96.
Gomollon F, Dignass A, Annese V, et al. 3rd European evidence-based consensus on the diagnosis and management of Crohn’s disease 2016: part 1: diagnosis and medical management. J Crohns Colitis. 2017;11:3–25.PubMedCrossRef
97.
Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management. J Crohns Colitis 2017;11:769–84.
98.
Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011;60:571–607.PubMedCrossRef
99.
Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113:481–517.PubMedCrossRef
100.
Sadowski DC, Bernstein CN, Bitton A, et al. Canadian Association of Gastroenterology clinical practice guidelines: the use of tumour necrosis factor-alpha antagonist therapy in Crohn’s disease. Can J Gastroenterol. 2009;23:185–202.PubMedPubMedCentralCrossRef
101.
Bressler B, Marshall JK, Bernstein CN, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015;148:1035–1058.e3.PubMedCrossRef
102.
103.
D’Haens GR, Panaccione R, Higgins PD, et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn’s and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response? Am J Gastroenterol. 2011;106:199–212.PubMedCrossRef
104.
Allen PB, Peyrin-Biroulet L. Moving towards disease modification in inflammatory bowel disease therapy. Curr Opin Gastroenterol. 2013;29:397–404.PubMedCrossRef
105.
Kang B, Choi SY, Choi YO, et al. Subtherapeutic infliximab trough levels and complete mucosal healing are associated with sustained clinical remission after infliximab cessation in paediatric-onset Crohn’s disease patients treated with combined immunosuppressive therapy. J Crohns Colitis. 2018;12:644–52.PubMedCrossRef
106.
Kang B, Choi SY, Kim HS, et al. Mucosal healing in paediatric patients with moderate-to-severe luminal Crohn’s disease under combined immunosuppression: escalation versus early treatment. J Crohns Colitis. 2016;10:1279–86.PubMedCrossRef
107.
Lee YS, Baek SH, Kim MJ, et al. Efficacy of early infliximab treatment for pediatric Crohn’s disease: a three-year follow-up. Pediatr Gastroenterol Hepatol Nutr. 2012;15:243–9.PubMedPubMedCentralCrossRef
108.
Schreiber S, Reinisch W, Colombel JF, et al. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn’s disease. J Crohns Colitis. 2013;7:213–21.PubMedCrossRef
109.
Colombel JF, Panaccione R, Bossuyt P, et al. Effect of tight control management on Crohn’s disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2018;390:2779–89.PubMedCrossRef
110.
Oh EH, Oh K, Han M, et al. Early anti-TNF/immunomodulator therapy is associated with better long-term clinical outcomes in Asian patients with Crohn’s disease with poor prognostic factors. PLoS One. 2017;12:e0177479.PubMedPubMedCentralCrossRef
111.
Rubin DT, Uluscu O, Sederman R. Response to biologic therapy in Crohn’s disease is improved with early treatment: an analysis of health claims data. Inflamm Bowel Dis. 2012;18:2225–31.PubMedCrossRef
112.
Schreiber S, Colombel J-F, Bloomfield R, et al. Increased response and remission rates in short-duration Crohn’s disease with subcutaneous certolizumab pegol: an analysis of PRECiSE 2 randomized maintenance trial data. Am J Gastroenterol. 2010;105:1574–82.PubMedCrossRef
113.
Sandborn WJ, Melmed GY, McGovern DPB, et al. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn’s disease: analyses from the 7-year PRECiSE 3 study. Aliment Pharmacol Ther. 2015;42:330–42.PubMedCrossRef
114.
Feagan BG, Lasch K, Lissoos T, et al. Rapid response to vedolizumab therapy in biologic-naive patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2018;17(130–8):e7.
115.
Feagan BG, Rubin DT, Danese S, et al. Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists. Clin Gastroenterol Hepatol. 2017;15(229–39):e5.
116.
Sands BE, Sandborn WJ, Van Assche G, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease in patients naive to or who have failed tumor necrosis factor antagonist therapy. Inflamm Bowel Dis. 2017;23:97–106.PubMedCrossRef
117.
Paramsothy S, Cleveland NK, Zmeter N, et al. The role of biosimilars in inflammatory bowel disease. Gastroenterol Hepatol. 2016;12:741–51.
118.
119.
Rawla P, Sunkara T, Raj JP. Role of biologics and biosimilars in inflammatory bowel disease: current trends and future perspectives. J Inflamm Res. 2018;11:215–26.PubMedPubMedCentralCrossRef
120.
Jorgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304–16.PubMedCrossRef
121.
122.
Kim NH, Lee JH, Hong SN, et al. Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2019;34:1523–32.PubMedCrossRef
123.
Milassin Á, Fábián A, Molnár T. Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective. Ther Adv Gastroenterol. 2019;12:1756284819842748.CrossRef
124.
Gonczi L, Gecse KB, Vegh Z, et al. Long-term efficacy, safety, and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort. Inflamm Bowel Dis. 2017;23:1908–15.PubMedCrossRef
125.
Kaur P, Chow V, Zhang N, et al. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis. 2017;76:526–33.PubMedPubMedCentralCrossRef
126.
Wynne C, Altendorfer M, Sonderegger I, et al. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects. Expert Opin Investig Drugs. 2016;25:1361–70.PubMedCrossRef
127.
Shin D, Lee Y, Kim H, et al. A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers. J Clin Pharm Ther. 2017;42:672–8.PubMedCrossRef
128.
Cohen S, Genovese MC, Choy E, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017;76:1679–87.PubMedPubMedCentralCrossRef
129.
Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018;77:914–21.PubMedPubMedCentral
130.
Weinblatt ME, Baranauskaite A, Niebrzydowski J, et al. Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol. 2018;70:40–8.PubMedCrossRef
131.
Joensuu JT, Huoponen S, Aaltonen KJ, et al. The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review. PLoS One. 2015;10:e0119683.PubMedPubMedCentralCrossRef
132.
Ferrario A, Humbert T, Kanavos P, et al. Strategic procurement and international collaboration to improve access to medicines. Bull World Health Organ. 2017;95:720–2.PubMedPubMedCentralCrossRef
133.
Severs M, Oldenburg B, van Bodegraven AA, et al. The economic impact of the introduction of biosimilars in inflammatory bowel disease. J Crohns Colitis. 2017;11:289–96.PubMed
134.
Gulacsi L, Pentek M, Rencz F, et al. Biosimilars for the management of inflammatory bowel diseases: economic considerations. Curr Med Chem. 2019;26:259–69.PubMedCrossRef
135.
Colombel JF, Ungaro R, Aggarwal S, et al. P692 Efficacy and safety of early biologic treatment of Crohn’s disease in adult and paediatric patients: a systematic review. J Crohns Colitis. 2018;12:S461.CrossRef
136.
Panaccione R, Colombel JF, Bossuyt P, et al. Long-term cost-effectiveness of tight control for Crohn’s disease with adalimumab-based treatment: economic evaluation beyond 48 weeks of CALM trial. J Crohns Colitis. 2018;1:S074–5.CrossRef
137.
Pillai N, Dusheiko M, Burnand B, et al. A systematic review of cost-effectiveness studies comparing conventional, biological and surgical interventions for inflammatory bowel disease. PLoS One. 2017;12:e0185500.PubMedPubMedCentralCrossRef
138.
Puolakka K, Kautiainen H, Möttönen T, et al. Early suppression of disease activity is essential for maintenance of work capacity in patients with recent-onset rheumatoid arthritis: five-year experience from the FIN-RACo trial. Arthritis Rheum. 2005;52:36–41.PubMedCrossRef
139.
Anis A, Zhang W, Emery P, et al. The effect of etanercept on work productivity in patients with early active rheumatoid arthritis: results from the COMET study. Rheumatology. 2009;48:1283–9.PubMedCrossRef
140.
141.
Berns M, Hommes DW. Anti-TNF-alpha therapies for the treatment of Crohn’s disease: the past, present and future. Expert Opin Investig Drugs. 2016;25:129–43.PubMedCrossRef
142.
Jha A, Upton A, Dunlop WC, et al. The budget impact of biosimilar infliximab (Remsima®) for the treatment of autoimmune diseases in five European countries. Adv Ther. 2015;32:742–56.PubMedPubMedCentralCrossRef
143.
Brodszky V, Baji P, Balogh O, et al. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S65–71.PubMedCrossRef
144.
145.
Khraishi M, Stead D, Lukas M, et al. Biosimilars: a multidisciplinary perspective. Clin Ther. 2016;38:1238–49.PubMedCrossRef
146.
Zheng MK, Shih DQ, Chen GC. Insights on the use of biosimilars in the treatment of inflammatory bowel disease. World J Gastroenterol. 2017;23:1932–43.PubMedPubMedCentralCrossRef
147.
Mitrev N, Vande Casteele N, Seow CH, et al. Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2017;46:1037–53.PubMedCrossRef
148.
Papamichael K, Juncadella A, Wong D, et al. Proactive therapeutic drug monitoring of adalimumab is associated with better long-term outcomes compared to standard of care in patients with inflammatory bowel disease. J Crohns Colitis. 2019;13:976–81.PubMedCrossRef
149.
Reinisch W, Eser A, Schreiber S, et al. Body weight and rapid clearance determine early formation of anti-drug antibodies against infliximab. United European Gastroenterol J. 2017;5(suppl 1):A102.
150.
Ricciuto A, Dhaliwal J, Walters TD, et al. Clinical outcomes with therapeutic drug monitoring in inflammatory bowel disease: a systematic review with meta-analysis. J Crohns Colitis. 2018;12:1302–15.PubMedCrossRef
151.
Roblin X, Riviere P, Flamant M, et al. Proactive therapeutic drug monitoring of TNF antagonists in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24:1904–9.PubMedCrossRef
152.
Ben-Horin S. Drug level-based anti-tumor necrosis factor therapy: ready for prime time? Gastroenterology. 2015;148:1268–71.PubMedCrossRef
153.
Martelli L, Olivera P, Roblin X, et al. Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review. J Gastroenterol. 2017;52:19–25.PubMedCrossRef
154.
155.
Aladul MI, Fitzpatrick RW, Chapman SR. Impact of infliximab and etanercept biosimilars on biological disease-modifying antirheumatic drugs utilisation and NHS budget in the UK. BioDrugs. 2017;31:533–44.PubMedCrossRef
156.
Jahnsen J, Kaasen Jorgensen K. Experience with biosimilar infliximab (Remsima®) in Norway. Dig Dis. 2017;35:83–90.PubMedCrossRef
157.
Lakatos P. European experience of infliximab biosimilars for the treatment of inflammatory bowel disease. Gastroenterol Hepatol. 2016;12:119–21.
158.
159.
Danese S, Fiorino G, Raine T, et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease-an update. J Crohns Colitis. 2017;11:26–34.PubMedCrossRef
160.
Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76:355–63.PubMedCrossRef
161.
Liu Y, Yang M, Garg V, et al. Economic impact of non-medical switching from originator biologics to biosimilars: a systematic literature review. Adv Ther. 2019;36:1851–77.PubMedPubMedCentralCrossRef
162.
Moorkens E, Simoens S, Troein P, et al. Different policy measures and practices between Swedish counties influence market dynamics: part 2-biosimilar and originator etanercept in the outpatient setting. BioDrugs. 2019;33:299–306.PubMedPubMedCentralCrossRef
163.
Danese S, Peyrin-Biroulet L. IBD: to switch or not to switch: that is the biosimilar question. Nat Rev Gastroenterol Hepatol. 2017;14:508–9.PubMedCrossRef
164.
Feagan BG, Lam G, Ma C, et al. Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab. Aliment Pharmacol Ther. 2019;49:31–40.PubMedCrossRef
165.
Blauvelt A, Lacour JP, Fowler JF Jr, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018;179:623–31.PubMedCrossRef
166.
Gerdes S, Thaçi D, Griffiths CEM, et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. J Eur Acad Dermatol Venereol. 2018;32:420–7.PubMedCrossRef
167.
Kemp K, Dibley L, Chauhan U, et al. Second N-ECCO consensus statements on the European nursing roles in caring for patients with Crohn’s disease or ulcerative colitis. J Crohns Colitis. 2018;12:760–76.PubMedCrossRef
168.
Peyrin-Biroulet L, Lonnfors S, Roblin X, et al. Patient perspectives on biosimilars: a survey by the European Federation of Crohn’s and Ulcerative Colitis Associations. J Crohns Colitis. 2017;11:128–33.PubMedCrossRef
169.
van Overbeeke E, De Beleyr B, de Hoon J, et al. Perception of originator biologics and biosimilars: a survey among Belgian rheumatoid arthritis patients and rheumatologists. BioDrugs. 2017;31:447–59.PubMedCrossRef
170.
Aladul MI, Fitzpatrick RW, Chapman SR. Patients’ understanding and attitudes towards infliximab and etanercept biosimilars: result of a UK web-based survey. BioDrugs. 2017;31:439–46.PubMedCrossRef
171.
Teeple A, Ginsburg S, Howard L, et al. Patient attitudes about non-medical switching to biosimilars: results from an online patient survey in the United States. Curr Med Res Opin. 2019;35:603–9.PubMedCrossRef
172.
Kristensen LE, Alten R, Puig L, et al. Non-pharmacological effects in switching medication: the nocebo effect in switching from originator to biosimilar agent. BioDrugs. 2018;32:397–404.PubMedPubMedCentralCrossRef
173.
174.
Pouillon L, Socha M, Demore B, et al. The nocebo effect: a clinical challenge in the era of biosimilars. Expert Rev Clin Immunol. 2018;14:739–49.PubMedCrossRef
175.
Scherlinger M, Germain V, Labadie C, et al. Switching from originator infliximab to biosimilar CT-P13 in real-life: the weight of patient acceptance. Joint Bone Spine. 2018;85:561–7.PubMedCrossRef
176.
Boone NW, Liu L, Romberg-Camps MJ, et al. The nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol. 2018;74:655–61.PubMedPubMedCentralCrossRef
177.
178.
Laugesen J, Hassanein K, Yuan Y. The impact of internet health information on patient compliance: a research model and an empirical study. J Med Internet Res. 2015;17:e143.PubMedPubMedCentralCrossRef
179.
Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36:1260–5.PubMedCrossRef
180.
181.
Jacobs I, Singh E, Sewell KL, et al. Patient attitudes and understanding about biosimilars: an international cross-sectional survey. Patient Prefer Adherence. 2016;10:937–48.PubMedPubMedCentralCrossRef
182.
Kim WS, Ogura M, Kwon H-C, et al. Looking to the future and learning lessons from the recent past: changing stakeholder perceptions of biosimilars in cancer. Future Oncol. 2017;13:17–29.PubMedCrossRef
183.
Leonard E, Wascovich M, Oskouei S, et al. Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review. J Manag Care Spec Pharm. 2019;25:102–12.PubMed
184.
Braun J, Kudrin A. Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health. Biologicals. 2016;44:257–66.PubMedCrossRef
185.
Danese S, Fiorino G, Michetti P. Changes in biosimilar knowledge among European Crohn’s Colitis Organization [ECCO] members: an updated survey. J Crohns Colitis. 2016;10:1362–5.PubMedCrossRef
186.
Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017;76:346–54.PubMedCrossRef
187.
Westhovens R, Yoo DH, Jaworski J, et al. Novel formulation of CT-P13 for subcutaneous administration in patients with rheumatoid arthritis: initial results from a phase I/III randomised controlled trial [THU0191, presented at EULAR 2018]. Ann Rheum Dis. 2018;77:315.CrossRef
188.
Reinisch W, Jang BI, Borzan V, et al. A novel formulation of CTP13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a phase I open-label randomised controlled trial in patients with active Crohn’s disease [abstract A1103, presented at ECCO 2019].
189.
Schreiber S, Jang BI, Borzan V, et al. Novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: Initial results from a phase I open-label randomized controlled trial in patients with active Crohn’s disease. Gastroenterology. 2018;154:S-1371.CrossRef
190.
Metadata
Title
The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases
Authors
HoUng Kim
Rieke Alten
Luisa Avedano
Axel Dignass
Fernando Gomollón
Kay Greveson
Jonas Halfvarson
Peter M. Irving
Jørgen Jahnsen
Péter L. Lakatos
JongHyuk Lee
Souzi Makri
Ben Parker
Laurent Peyrin-Biroulet
Stefan Schreiber
Steven Simoens
Rene Westhovens
Silvio Danese
Ji Hoon Jeong
Publication date
01-02-2020
Publisher
Springer International Publishing
Published in
Drugs / Issue 2/2020
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-020-01256-5

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