Current state of biologic pharmacovigilance in the European Union: improvements are needed
| Autor: | John B. Jordan, Thomas Felix, Bina Patel, Catherine Akers, Daniela Drago |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Traceability
Drug-Related Side Effects and Adverse Reactions Legislation 030204 cardiovascular system & hematology Biological drugs 03 medical and health sciences Pharmacovigilance 0302 clinical medicine Medicine media_common.cataloged_instance Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) European Union European union Biosimilar Pharmaceuticals media_common Biological Products business.industry Biosimilar General Medicine Adr reporting Risk analysis (engineering) 030220 oncology & carcinogenesis business Relevant information |
| Zdroj: | Expert opinion on drug safety. 18(3) |
| ISSN: | 1744-764X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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