摘要
生物制药在全球范围内的应用日益广泛，在肿瘤治疗及肿瘤支持治疗领域占重要地位，随着原研药物专利到期，应运而生的便是生物类似药。生物类似药被定义为与原研药物高度相似、但不完全相同的生物药品，其研发及审评过程均不同于小分子化学仿制药。生物类似药有望降低全球范围内医疗保健系统的支出，在肿瘤治疗领域，正迎来利妥昔单抗、曲妥珠单抗和贝伐珠单抗生物类似药的研发热潮，有望在未来的几年中优化临床决策及患者治疗选择，降低政府医药费用支出。文章介绍了生物类似药的研发现状，重点介绍了肿瘤领域生物类似药研发所面临的机遇及挑战。
With the extensive application in clinical practice, biological medicine plays a significant role in both treatment and supportive care in oncology. With the expiration of original drug patents, biosimilars emerge. The biosimilars are defined as biological drugs that are be highly similar but not identical to the biological reference. Their development and evaluation procedure are different from those of small molecular chemical generics. Biosimilars are expected to reduce the health care costs worldwide. The booming developments of biosimilars, such as rituximab, trastuzumab and bevacizumab in medical oncology can optimize the clinical strategies, offer patients more treatment options and reduce the medical expenditure. In this article, we review the advances in the field of biosimilars, especially focus on the challenges and opportunities of biosimilars in clinical oncology.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
2017年第10期721-725,共5页
Chinese Journal of Oncology
