Otte Maximilian, Kaló Zoltán, Al-Omar Hussain Abdulrahman, Boysen Meindert, Chen Yingyao, Etges Ana Paula Beck Da Silva, Kockaya Guvenc, Gutierrez-Ibarluzea Iñaki, Seyam Ahmed Mohammed, Mullen Deirdre, Dauben Hans-Peter
OITBpathway V. o. G., Eupen, Belgium.
Institut für Gesundheit und Gesellschaft (I2GG), Cologne, Germany.
Front Pharmacol. 2025 Aug 13;16:1599013. doi: 10.3389/fphar.2025.1599013. eCollection 2025.
Biosimilar medicines play a critical role in enhancing global health outcomes by improving access to effective biologic treatments. However, their acceptance and implementation, particularly in emerging markets, depend not only on clinical evidence but also on the integration of societal, individual, and cultural values. This paper explores how value-based decision-making can support the adoption of biosimilars across diverse contexts.
A multi-stakeholder workshop was conducted with participants from various countries, focusing on decision-making processes for biosimilars in emerging health systems. Discussions addressed stakeholder roles, contextual influences, and the alignment of evidence with values. A Multi-Criteria Decision Analysis (MCDA) framework was proposed as a tool to systematically integrate measurable outcomes and intangible factors such as trust, perceived quality, and cultural acceptance.
Key barriers identified included regulatory uncertainties, limited local evidence, regional data protection constraints, and patient preferences for originator biologics. Participants emphasized the importance of adaptable frameworks that reflect local cultural, economic, and systemic conditions. The proposed MCDA approach was viewed as a promising method for capturing complex value dimensions and facilitating transparent, inclusive decision-making. Broader societal benefits of biosimilars, such as economic development through local production, were also highlighted.
The workshop underscored the need for value-sensitive implementation strategies that go beyond clinical effectiveness. Integrating context-specific values into evidence-based decision-making can foster trust and support the sustainable adoption of biosimilars. The MCDA framework offers a structured approach to operationalize these principles. Future research should test and refine this model in varied health system settings to support its practical application by policymakers, healthcare providers, and industry stakeholders.
生物类似药通过改善有效生物治疗的可及性，在提升全球健康成果方面发挥着关键作用。然而，它们的接受度和应用情况，尤其是在新兴市场，不仅取决于临床证据，还取决于社会、个人和文化价值观的融合。本文探讨基于价值的决策如何支持生物类似药在不同背景下的采用。
与来自不同国家的参与者举办了一次多利益相关方研讨会，重点关注新兴卫生系统中生物类似药的决策过程。讨论涉及利益相关方的角色、背景影响以及证据与价值观的一致性。提出了多标准决策分析（MCDA）框架，作为一种系统整合可衡量结果和无形因素（如信任、感知质量和文化接受度）的工具。
确定的主要障碍包括监管不确定性、本地证据有限、区域数据保护限制以及患者对原研生物药的偏好。参与者强调了反映当地文化、经济和系统状况的适应性框架的重要性。所提出的MCDA方法被视为一种有前景的方法，用于捕捉复杂的价值维度并促进透明、包容的决策。还强调了生物类似药更广泛的社会效益，如通过本地生产促进经济发展。
研讨会强调了超越临床有效性的价值敏感实施策略的必要性。将特定背景的价值观纳入基于证据的决策可以增强信任并支持生物类似药的可持续采用。MCDA框架提供了一种结构化方法来实施这些原则。未来的研究应在不同的卫生系统环境中测试和完善该模型，以支持政策制定者、医疗保健提供者和行业利益相关者的实际应用。
