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
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