Colegio de Ciencias de la Salud, Universidad San Francisco de Quito, Quito, Ecuador.
Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.
Lancet Oncol. 2022 Jul;23(7):e348-e358. doi: 10.1016/S1470-2045(22)00121-8.
In a multiday conference, a panel of Latin American experts in biological cancer therapies and health economics were provided with questions to address the barriers restricting access to biosimilars in Latin America, specifically for patients with breast cancer and colorectal cancer, for whom biosimilars can be a path forward to increasing access to care. During the conference, responses were discussed and edited until a consensus was achieved. The regulatory challenges identified in the conference included heterogenous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars by only using international non-proprietary names, imprecise use of interchangeability and substitution, and insufficient traceability and pharmacovigilance. Recommendations were developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to these therapies with adequate traceability and outcome measures; efforts from all involved stakeholders will be crucial. These recommendations can serve as a strategy for biosimilar adoption in other countries in a similar situation.
在一次为期多天的会议上，一组拉丁美洲生物癌症治疗和卫生经济学专家收到了一些问题，这些问题旨在探讨限制拉丁美洲生物类似药获取的障碍，特别是针对乳腺癌和结直肠癌患者，因为生物类似药可以为增加他们获得治疗的机会提供途径。在会议期间，对回复进行了讨论和编辑，直到达成共识。会议中确定的监管挑战包括监管规定存在差异、不遵守监管途径、市场机会稀缺、仅使用国际非专利名称对生物类似药进行命名、互换和替代的使用不精确，以及可追溯性和药物警戒不足。会议制定了一些建议，以改善监管途径的实施和可靠的采购策略，从而增加这些疗法的可及性，并采取适当的可追溯性和结果措施；所有相关利益攸关方的努力都至关重要。这些建议可以作为在其他类似情况下采用生物类似药的一种策略。
