Vizgirda Vida, Jacobs Ira
NorthShore University HealthSystem.
Pfizer Inc.
Clin J Oncol Nurs. 2017 Apr 1;21(2):E54-E60. doi: 10.1188/17.CJON.E54-E60.
Biosimilars are developed to be highly similar to and treat the same conditions as licensed biologics. As they are approved and their use becomes more widespread, oncology nurses should be aware of their development and unique considerations.
OBJECTIVES: This article reviews properties of biosimilars; their regulation and approval process; the ways in which their quality, safety, and efficacy are evaluated; their postmarketing safety monitoring; and their significance to oncology nurses and oncology nursing. .
METHODS: A search of PubMed and regulatory agency websites was conducted for references related to the development and use of biosimilars in oncology. .
Because biologics are large, structurally complex molecules, biosimilars cannot be considered generic equivalents to licensed biologic products. Consequently, regulatory approval for biosimilars is different from approval for small-molecule generics. Oncology nurses are in a unique position to educate themselves, other clinicians, and patients and their families about biosimilars to ensure accurate understanding, as well as optimal and safe use, of biosimilars.
生物类似药的研发目的是与已获许可的生物制品高度相似并治疗相同病症。随着它们获得批准且使用日益广泛，肿瘤护理人员应了解其研发情况及独特的注意事项。
本文综述了生物类似药的特性、监管与审批流程、质量、安全性和有效性的评估方式、上市后安全监测以及对肿瘤护理人员和肿瘤护理工作的意义。
在PubMed和监管机构网站上搜索与生物类似药在肿瘤学领域的研发和使用相关的参考文献。
由于生物制品是大分子、结构复杂的分子，生物类似药不能被视为已获许可生物制品的通用等效物。因此，生物类似药的监管批准与小分子仿制药的批准不同。肿瘤护理人员处于独特的地位，能够对自己、其他临床医生以及患者及其家属进行有关生物类似药方面的教育，以确保对生物类似药有准确的理解，并能实现其最佳和安全的使用。
