Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases

被引:20
作者
Edwards, Christopher J. [1 ]
Hercogova, Jana [2 ,3 ]
Albrand, Helene [4 ]
Amiot, Aurelian [5 ,6 ]
机构
[1] Univ Hosp Southampton NHS Fdn Trust, NIHR Clin Res Facil, Southampton, Hants, England
[2] Charles Univ Prague, Med Fac 2, Dermatol Dept, Prague, Czech Republic
[3] Na Bulovce Hosp, Prague, Czech Republic
[4] Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland
[5] Paris Est Creteil Univ, Henri Mondor Hosp, AP HP, Dept Gastroenterol, Creteil, France
[6] Paris Est Creteil Univ, Henri Mondor Hosp, AP HP, Unit EC2M3 EA7375, Creteil, France
关键词
Biological therapy; biosimilar; immune-mediated inflammatory disease; switching; 2 ETANERCEPT AUTOINJECTORS; EARLY RHEUMATOID-ARTHRITIS; CROHNS-DISEASE; BOWEL-DISEASE; DOUBLE-BLIND; REFERENCE INFLIXIMAB; EFFICACY; SAFETY; METHOTREXATE; THERAPY;
D O I
10.1080/14712598.2019.1610381
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
Introduction: The expiry of patents for biologics has led to the introduction of biosimilars for the treatment of immune-mediated inflammatory diseases (IMIDs). These treatment alternatives may allow earlier and wider access to appropriate therapy for patients without increasing the economic burden on health-care systems. Prescription of biosimilars to treatment-naive patients is well accepted; however, additional considerations must be taken into account when switching clinically stable patients from reference products to biosimilars. Area covered: We discuss the current considerations related to switching from reference products to biosimilars from a physician and patient perspective. We review the clinical data and real-life experience on switching patients with IMIDs, present the position of the relevant medical societies, and discuss the importance of patient-physician communication and need for shared decision-making. Expert opinion: The introduction of biosimilars provides an opportunity to expand access to treatment for patients with IMIDs across Europe and support the financial sustainability of health-care systems. We anticipate that as the real-world evidence base grows, confirming the results of clinical trials, there will be a corresponding increase in physician and patient acceptance, not only to initiating treatment with a biosimilar, but also to switching medication from a reference product to a biosimilar.
引用
收藏
页码:1001 / 1014
页数:14
相关论文
共 108 条
[81]   Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country's wealth? [J].
Putrik, Polina ;
Ramiro, Sofia ;
Kvien, Tore K. ;
Sokka, Tuulikki ;
Uhlig, Till ;
Boonen, Annelies .
ANNALS OF THE RHEUMATIC DISEASES, 2014, 73 (11) :2010-2021
[82]   Systematic review with meta-analysis: loss of response and requirement of anti-TNFα dose intensification in Crohn's disease [J].
Qiu, Yun ;
Chen, Bai-li ;
Mao, Ren ;
Zhang, Sheng-hong ;
He, Yao ;
Zeng, Zhi-rong ;
Ben-Horin, Shomron ;
Chen, Min-hu .
JOURNAL OF GASTROENTEROLOGY, 2017, 52 (05) :535-554
[83]   Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme [J].
Razanskaite, Violeta ;
Bettey, Marion ;
Downey, Louise ;
Wright, Julia ;
Callaghan, James ;
Rush, Miles ;
Whiteoak, Simon ;
Ker, Sarah ;
Perry, Kim ;
Underhill, Caron ;
Efrem, Eren ;
Ahmed, Iftikar ;
Cummings, Fraser .
JOURNAL OF CROHNS & COLITIS, 2017, 11 (06) :690-696
[84]   Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe [J].
Rencz, Fanni ;
Pentek, Marta ;
Bortlik, Martin ;
Zagorowicz, Edyta ;
Hlavaty, Tibor ;
Sliwczynski, Andrzej ;
Diculescu, Mihai M. ;
Kupcinskas, Limas ;
Gecse, Krisztina B. ;
Gulacsi, Laszlo ;
Lakatos, Peter L. .
WORLD JOURNAL OF GASTROENTEROLOGY, 2015, 21 (06) :1728-1737
[85]   To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars [J].
Rezk, Mourad F. ;
Pieper, Burkhard .
ADVANCES IN THERAPY, 2018, 35 (06) :749-753
[86]   Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect [J].
Rezk, Mourad F. ;
Pieper, Burkhard .
RHEUMATOLOGY AND THERAPY, 2017, 4 (02) :209-218
[87]   Switching from originator infliximab to biosimilar CT-P13 in real-life: The weight of patient acceptance [J].
Scherlinger, Marc ;
Germain, Vincent ;
Labadie, Celine ;
Barnetche, Thomas ;
Truchetet, Marie-Elise ;
Bannwarth, Bernard ;
Mehsen-Cetre, Nadia ;
Richez, Christophe ;
Schaeverbeke, Thierry .
JOINT BONE SPINE, 2018, 85 (05) :561-567
[88]   Biosimilars from a practicing rheumatologist perspective: An overview [J].
Schimizzi, Gregory F. .
AUTOIMMUNITY REVIEWS, 2016, 15 (09) :911-916
[89]   Switching from infliximab innovator to biosimilar in patients with inflammatory bowel disease: a 12-month multicentre observational prospective cohort study [J].
Schmitz, E. M. H. ;
Boekema, P. J. ;
Straathof, J. W. A. ;
van Renswouw, D. C. ;
Brunsveld, L. ;
Scharnhorst, V. ;
van de Poll, M. E. C. ;
Broeren, M. A. C. ;
Derijks, L. J. J. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2018, 47 (03) :356-363
[90]   Drug Survival and Immunogenicity After Switching From Remicade to Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: Two-year Follow-up of a Prospective Observational Cohort Study [J].
Smits, Lisa J. T. ;
van Esch, Aura A. J. ;
Derikx, Lauranne A. A. P. ;
Boshuizen, Ronald ;
de Jong, Dirk J. ;
Drenth, Joost P. H. ;
Hoentjen, Frank .
INFLAMMATORY BOWEL DISEASES, 2019, 25 (01) :172-179