Clinical Oncology Pharmacy Specialist, Department of Pharmacy, Memorial Sloan Kettering Cancer Center, New York, NY. Email:
Am J Manag Care. 2018 Nov;24(21 Suppl):S451-S456.
The introduction of biologic therapies has improved the treatment landscape for multiple diseases, particularly in the areas of oncology, rheumatology, and endocrinology. Although they are effective, biologics are associated with increased costs that result in economic burden for healthcare professionals and patients. Biosimilars are biologic medical products that are almost an identical copy of the original product. There are differences in the regulatory requirements for the original biologic product and a biosimilar, as biosimilars gain FDA approval through an abbreviated approval pathway. The incorporation of these products into the US market will potentially result in improved patient access and decreased healthcare costs. There are barriers, such as lack of familiarity, that affect the use of biosimilars. Strategies to overcome these barriers are essential to improve the uptake of these products in the United States.
生物制剂的引入改善了多种疾病的治疗前景，特别是在肿瘤学、风湿病学和内分泌学领域。尽管它们很有效，但生物制剂也会带来更高的成本，给医疗保健专业人员和患者带来经济负担。生物类似药是指与原研生物制品几乎完全相同的生物医学产品。由于生物类似药通过简化的审批途径获得 FDA 批准，因此其在监管要求方面与原研生物制品存在差异。这些产品在美国市场的应用将有可能提高患者的可及性并降低医疗成本。存在一些障碍，如缺乏熟悉度，会影响生物类似药的使用。克服这些障碍的策略对于提高这些产品在美国的使用率至关重要。
