Abstract

Introduction: Little is known about market access of biosimilars from a health economic perspective, except for studies that compute the budget impact of biosimilar use.

Areas covered: This comprehensive health economic guide to the market access of biosimilars focuses on the role of biosimilars in pharmaceutical innovation and competition, the objective of biopharmaceutical policy, the budget impact of biosimilars, and the cost-effectiveness of biologic therapy in the presence of biosimilars.

Expert opinion: We argue that the objective of biopharmaceutical policy in a health system should be to create a competitive and sustainable market for off-patent reference biologics, biosimilars and next-generation biologics that makes biologic therapy available to patients at the lowest cost. Market access of biosimilars can contribute to this objective as a result of the lower price of biosimilars and price competition with alternative therapies. The resulting improvement in the cost-effectiveness of biologic therapy needs to be accounted for by revisiting reimbursement decision and conditions. When examining the cost-effectiveness of biologic therapy following patent expiry, stakeholders need to consider residual uncertainties at the time of biosimilar marketing authorisation, the nocebo effect, market entry of a second-generation reference biologic with a different administration form than the biosimilar, and value-added services.

摘要

简介：从健康经济学的角度对生物仿制药的市场准入知之甚少，但有关计算生物仿制药使用的预算影响的研究除外。

涵盖的领域：这份有关生物仿制药市场准入的全面健康经济指南，重点关注生物仿制药在药物创新和竞争中的作用，生物制药政策的目标，生物仿制药的预算影响以及存在生物仿制药时的成本效益。生物仿制药。

专家意见：我们认为，卫生系统中生物药物政策的目标应该是为专利非专利参考生物制剂，生物仿制药和下一代生物制剂创建一个竞争性和可持续性市场，以最低的成本为患者提供生物治疗。由于生物仿制药价格较低以及与替代疗法的价格竞争，生物仿制药的市场准入可有助于实现这一目标。需要通过重新确定报销的决定和条件来考虑生物治疗成本效益的最终改善。在审查专利到期后的生物疗法的成本效益时，利益相关者需要考虑生物仿制药上市授权时的残留不确定性，nocebo效应，