Current state of biologic pharmacovigilance in the European Union: improvements are needed

被引:20
作者
Felix, Thomas [1 ]
Jordan, John B. [2 ]
Akers, Catherine [3 ,6 ]
Patel, Bina [4 ]
Drago, Daniela [5 ]
机构
[1] Amgen Inc, Global Regulatory & R&D Policy, Washington, DC 20005 USA
[2] Amgen Inc, Global Regulatory & R&D Policy, Thousand Oaks, CA 91320 USA
[3] Amgen Ltd, Global Regulatory & R&D Policy, Cambridge, England
[4] Amgen Ltd, Global Patient Safety, Cambridge, England
[5] George Washington Univ, Sch Med & Hlth Sci, Regulatory Affairs, Washington, DC 20052 USA
[6] DLRC Ltd, Exeter House, Letchworth Garden City, England
关键词
Adverse drug reactions; biopharmaceuticals; biosimilars; pharmacovigilance; RED-CELL APLASIA; BIOSIMILARS CONSIDERATIONS; DOUBLE-BLIND; BIOPHARMACEUTICALS; IMMUNOGENICITY; TRACEABILITY; SURVEILLANCE; SYSTEMS;
D O I
10.1080/14740338.2019.1577818
中图分类号
R9 [药学];
学科分类号
100702 [药剂学];
摘要
Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010. Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved. Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.
引用
收藏
页码:231 / 240
页数:10
相关论文
共 70 条
[1]
Development and 10-year history of a biosimilar: the example of Binocrit® [J].
Aapro, Matti ;
Krendyukov, Andriy ;
Hoebel, Nadja ;
Seidl, Andreas ;
Gascon, Pere .
THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY, 2018, 10 :1-8
[2]
[Anonymous], BIOSIMILAR NAMING AD
[3]
[Anonymous], LYG PLATF REG INN
[4]
[Anonymous], YELLOWCARD FAQS
[5]
[Anonymous], FACT SHEET EX DIFF R
[6]
[Anonymous], ICH HARMONISED TRIPA
[7]
[Anonymous], LEG FRAM
[8]
[Anonymous], PHARM BIOL
[9]
[Anonymous], 2015, BIOL QUAL INN PROP
[10]
[Anonymous], PERSPECTIVES TRENDS