title: Biosimilars: A new scenario in biologic therapies.
abstract: There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events.
authors.affiliation: Servicio de Farmacia Hospitalaria, Hospital de La Princesa, IIS-IP, Universidad Autónoma, Madrid, España.
authors.forename: José M
authors.initials: JM
authors.lastname: Serra López-Matencio
authors.affiliation: Servicio de Farmacia Hospitalaria, Hospital de La Princesa, IIS-IP, Universidad Autónoma, Madrid, España.
authors.forename: Alberto
authors.initials: A
authors.lastname: Morell Baladrón
authors.affiliation: Servicio de Reumatología, Hospital de La Princesa, IIS-IP, Universidad Autónoma, Madrid, España. Electronic address: santos.castaneda@salud.madrid.org.
authors.forename: Santos
authors.initials: S
authors.lastname: Castañeda
mesh_terms: D001691:Biological Therapy / Q000009:adverse effects*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects* / Q000191:economics; D004335:Drug and Narcotic Control; D005060:Europe; D006801:Humans; D061214:Patient Safety; D060735:Pharmacovigilance
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: Acontecimientos adversos; Adverse reactions; Biologics; Biológicos; Biosimilares; Biosimilars; Farmacovigilancia; Legislación; Legislation; Pharmacovigilance; Traceability; Trazabilidad