Center for Pharmacy Practice Excellence, Vizient, Irving, TX. Email:
Am J Manag Care. 2018 Jun;24(11 Suppl):S237-S243.
There are now 10 approved biosimilars in the United States, including 3 oncology drugs, and at least 16 others in late-stage development. The introduction of competition into the biologic space launches a new era in the treatment of cancer, possibly increasing access to the extremely costly biologics. The most important and influential stakeholders for biosimilar acceptance and usage are healthcare providers, such as pharmacists and physicians, as well as patients. Gaining their support requires extensive education, postmarketing pharmacovigilance, resolving concerns about immunogenicity, and allowing interchangeability and substitution. Patients require education on the basic definition of biosimilars versus generic drugs, how biosimilars are tested and approved, costs, and availability of clinical trials. Meanwhile, payers may need to find ways to incentivize physicians to prescribe biosimilars over biologics, as well as to provide information on cost and quality directly to patients in order to drive uptake. Finally, legal challenges to approved and pending biosimilars have limited the market access of these agents.
目前美国已有 10 种获批的生物类似药，其中包括 3 种肿瘤药物，还有至少 16 种处于后期开发阶段。生物类似药的引入开创了癌症治疗的新时代，可能会增加获得极其昂贵生物制剂的机会。对于生物类似药的接受和使用而言，最重要和最有影响力的利益相关者是医疗保健提供者，如药剂师和医生，以及患者。获得他们的支持需要进行广泛的教育、上市后药物警戒、解决免疫原性问题的担忧，并允许互替和替代。患者需要了解生物类似药与仿制药的基本定义、生物类似药的测试和批准、成本以及临床试验的可用性。同时，支付方可能需要找到激励医生开处方使用生物类似药而不是生物制剂的方法，以及向患者直接提供关于成本和质量的信息，以推动其使用。最后，针对已获批和待批生物类似药的法律挑战限制了这些药物的市场准入。
