Portela Maria da Conceição Constantino, Sinogas Carlos, Albuquerque de Almeida Fernando, Baptista-Leite Ricardo, Castro-Caldas Alexandre
a Instituto de Ciências da Saúde , Universidade Católica Portuguesa , Lisboa , Portugal.
b ACF - Acompanhamento Farmacoterapêutico, Lda , Pavia , Portugal.
Expert Opin Biol Ther. 2017 Jul;17(7):871-877. doi: 10.1080/14712598.2017.1330409. Epub 2017 May 25.
Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution. The terminology, information systems and traceability systems aren't entirely appropriate to ensure the safety requirements for therapy with medicinal products of a biological origin. Areas covered: This article aims to identify the prescription and dispensing profiles of reference biological medicines and biosimilars in the EU, and the determinants that support their safe use. Expert opinion: The European pharmacovigilance system must evolve to ensure the safety along all of the biologicals' therapeutic cycle. It must consider the safety for each of the medicines in addition to their safety pattern related to the eventual switching procedure.
生物源药品由欧洲药品管理局（EMA）在集中层面批准。然而，在欧洲，其使用情况并不统一。目前已确定了欧洲现行的有关生物药品和生物类似药安全性的法规。生物源药品的安全性由药物警戒系统保障，该系统虽已发展，但尚未纳入该市场领域的所有特定信息，即与药品识别及其使用相关的信息——包括处方和配药，鉴于存在可互换性和可替代性。术语、信息系统和追溯系统并不完全适合确保生物源药品治疗的安全要求。涵盖领域：本文旨在确定欧盟中参比生物药和生物类似药的处方和配药情况，以及支持其安全使用的决定因素。专家意见：欧洲药物警戒系统必须不断发展，以确保生物药品整个治疗周期的安全性。除了考虑与最终换药程序相关的安全模式外，还必须考虑每种药品的安全性。
