Biopharmaceuticals safety perception in Slovakia: considerations and real-life pharmacovigilance data

Bratislava Medical Journal

article

M. Lassanova¹  S. Liskova¹  J. Tisonova¹  S. Fundarkova²  S. Lassan³ 

[1] Institute of Pharmacology and Clinical Pharmacology, Faculty of Medicine, Comenius University;Section of Clinical Trials of Medicinal Products and Pharmacovigilance, State Institute for Drug Control;Department of Pneumology and Phthisiology and Functional Diagnostics, Slovak Medical University and University Hospital Bratislava

关键词: adverse drug reaction;    spontaneous reporting;    biopharmaceuticals;    biosimilars;    infliximab;   

DOI  :  10.4149/BLL_2021_073

学科分类：医学（综合）

来源: AEPress, s.r.o.

【 摘 要 】

OBJECTIVES: Biopharmaceuticals improved the prognosis and quality of life of patients with chronic diseases. The aim of our study was to analyse the total reported suspected adverse drug reactions (ADR) and ADRs of reference biologicals and their biosimilars in Slovakia. METHODS: Using data from the State Institute for Drug Control database, we analysed the trends of suspected ADR submitted between 2001–2017 including the registered biosimilars and their reference biologicals: erythropoietin, filgrastim and infliximab. RESULTS: Severe suspected ADR represented 42.95 % from all the reported cases (n=13,462) over the time period 2006–2017 and 54.98 % over 2015–2017 respectively. Reports from 2015–2017 were further analysed. From 4,364 cases, 27 were associated with infliximab and one with erythropoietin. 75 % of these ADR were severe including one death. The difference between the suspected ADR for infliximab reference biological compared to the biosimilar was not statistically significant (p=0.171) after adjustment to the number of prescribed drug units. CONCLUSION: We did not find any evidence of increased risks associated with biosimilars compared to reference biologics. The spontaneous reporting system represents an inexpensive tool of reporting ADRs and should be utilized more frequently by health professionals, but even more importantly, by patients.

【 授权许可】

CC BY