Manager, Medication Policy and Formulary Management, Yale New Haven Health System, New Haven, CT. Email:
Am J Manag Care. 2018 Nov;24(21 Suppl):S457-S461.
With the passing and implementation of the Biologics Price Competition and Innovation Act in 2010, biosimilars became a new classification of FDA-approved drugs. The biosimilar classification, created with a streamlined drug approval process, was intended to spur competition and reduce the cost of biological product therapies. Since the first FDA-approved biosimilar in 2015, the impact of biosimilars on the US biological product market remains to be seen. As more biosimilar products are approved and marketed, cost-savings are expected with predictions ranging from $54 billion to $250 billion by the mid-2020s. However, a multitude of factors may diminish the cost-saving potential of biosimilars. For biosimilars to gain market share, patients, physicians, and other healthcare professionals will need to accept biosimilars as safe and effective alternatives to reference-biologic products. A key factor in gaining this acceptance is educating the public, physicians, and healthcare professionals on the rigorous approval standards required of biosimilars by the FDA. Other factors that will affect market share of biosimilars include litigation actions by biopharmaceutical manufacturers; positions stated by physician organizations; and the influences of insurers and managed care. The clinical and basic science required for biosimilar approvals will be major underlying elements driving biosimilar acceptance and increased market presence.
随着 2010 年《生物类似药价格竞争与创新法案》的通过和实施，生物类似药成为了 FDA 批准药物的一个新分类。这个生物类似药分类采用了简化的药物审批程序，旨在促进竞争并降低生物制品治疗的成本。自 2015 年首个 FDA 批准的生物类似药以来，生物类似药对美国生物制品市场的影响仍有待观察。随着更多的生物类似药产品获得批准和上市，预计到 2020 年代中期，成本节约将达到 540 亿至 2500 亿美元。然而，许多因素可能会降低生物类似药的成本节约潜力。为了使生物类似药获得市场份额，患者、医生和其他医疗保健专业人员需要将生物类似药视为与参照生物制品安全且等效的替代药物。获得这种认可的一个关键因素是向公众、医生和医疗保健专业人员宣传 FDA 对生物类似药所要求的严格审批标准。影响生物类似药市场份额的其他因素包括生物制药制造商的诉讼行动；医师组织的立场；以及保险公司和管理式医疗的影响。生物类似药批准所需的临床和基础科学将是推动生物类似药接受度和增加市场占有率的主要潜在因素。
