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Curr Pharm Des. 2017;23(44):6779-6783. doi: 10.2174/1381612824666171129192607.
Biosimilars have the potential to create competition, lower costs, and increase patient access to biological medications. However, biological medications are sensitive to their manufacturing processes and difficult to precisely characterize, leading to questions about substitution and interchangeability among products.
This article reviews the role of biosimilars in patient access to therapeutic antibodies.
Although pathways for the approval of biosimilars have been developed, important issues remain unresolved. Interchangeability, or the designation of one medicine as clinically similar to and/or substitutable for another, is specified in some countries but restricted or awaiting policy resolution in others. Non-medical switching, or the switching among biological medications to select a less expensive product, for reasons unrelated to patient health and safety, is controversial because of the potential for complications related to repeated switching (e.g., immunogenicity and loss of therapeutic effect), and transfer of prescribing responsibility for patient medications from the physician to the insurance company. Although biosimilars have different names in different countries, the World Health Organization (WHO) calls for nomenclature that incorporates the international nonproprietary name of the original biological medication followed by a distinguishing suffix qualifier. Naming consistency across countries seems sensible, and adoption of the WHO recommended suffix would greatly simplify pharmacovigilance.
Support for the WHO proposal is advised by numerous stakeholders, and resolution of the remaining outstanding issues is urged so that patients and physicians can safely access biosimilars.
生物类似药具有创造竞争、降低成本和增加患者获得生物药物机会的潜力。然而，生物药物对其制造工艺敏感，难以精确表征，这导致了产品之间替代和可互换性的问题。
本文综述了生物类似药在患者获得治疗性抗体方面的作用。
尽管已经开发出生物类似药的批准途径，但仍存在一些重要问题尚未解决。可互换性，即一种药物在临床上被认为与另一种药物相似和/或可替代，在一些国家有所规定，但在其他国家则受到限制或等待政策解决。非医疗转换，即在不涉及患者健康和安全的情况下，出于经济原因在生物药物之间进行转换，以选择更便宜的产品，这是有争议的，因为重复转换可能会导致与免疫原性和治疗效果丧失相关的并发症，并且将患者药物的处方责任从医生转移到保险公司。尽管生物类似药在不同国家有不同的名称，但世界卫生组织（WHO）呼吁采用包含原始生物药物国际非专利名称的命名法，并加上区别后缀标识符。国家之间的命名一致性似乎是合理的，采用 WHO 建议的后缀将极大地简化药物警戒。
许多利益相关者支持 WHO 的提案，并敦促解决剩余的未决问题，以便患者和医生能够安全地获得生物类似药。
