Center for Pharmacy Practice Excellence, Vizient, Irving, TX. Email:
Am J Manag Care. 2018 Jun;24(11 Suppl):S231-S236.
Created via the Biologics Price Competition and Innovation Act, the biosimilar class of drugs was conceived as an opportunity to introduce competition for commonly used biologics following loss of patent protection and market exclusivity, similar to the generic paradigm that has helped sustain access and innovation for more than 3 decades. The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without any clinically meaningful differences in safety, purity, and potency. Given the concerns about increasing healthcare costs and this new opportunity to reduce the expense associated with biologics, including many commonly used oncology medications, the use of biosimilars will likely increase as numerous stakeholders, including managed care organizations, begin to implement policies to encourage adoption. As biosimilars are a relatively new class of drugs, clinical, scientific, and regulatory aspects continue to evolve and improve. Understanding those various aspects can improve clinician acceptance and advance the science of biologics and biosimilars. In this report, various factors are addressed to improve the knowledge of biosimilars, including clinical, manufacturing, and cost considerations.
根据《生物类似药竞争和创新法案》（Biologics Price Competition and Innovation Act），生物类似药是在专利保护和市场专有权到期后，为引入常用生物制剂竞争而设想的一种药物类别，类似于已经帮助维持了 30 多年的仿制药模式，为人们提供了获得药物和创新的机会。FDA 在制造商确定产品与以前批准的原创生物参考产品高度相似，且在安全性、纯度和效力方面没有任何临床意义上的差异后，批准生物类似药。鉴于人们对医疗保健成本不断上升的担忧，以及这一新机会可以降低与生物制剂相关的费用，包括许多常用的肿瘤药物，随着包括管理式医疗组织在内的众多利益相关者开始实施鼓励采用的政策，生物类似药的使用可能会增加。由于生物类似药是一种相对较新的药物类别，其临床、科学和监管方面仍在不断发展和完善。了解这些不同方面可以提高临床医生的接受程度，并推进生物制剂和生物类似药的科学发展。在本报告中，将讨论各种因素，以提高对生物类似药的认识，包括临床、制造和成本方面的考虑。
