Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective.

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.

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Declaration of interests ET reports honoraria from Abbott, Bayer, Janssen, Heel, Medicamenta, Merck, MSD, Novartis, Pfizer, Roche, and Sanofi, outside of the submitted work. HG reports consulting fees and honoraria from Bristol Myers Squibb (BMS), MSD, Roche, and AstraZeneca, outside of the submitted work. DH reports honoraria from MSD, Roche, Tecnofarma, and Pfizer, outside of the submitted work. WM reports grants from Pfizer and Amgen, and honoraria from Pfizer, Amgen, and Novartis, outside of the submitted work. MAE reports grants from Fondo Nacional de Desarrollo Científico y Tecnológico, Agencia Nacional de Investigación y Desarrollo, Asociación Chilena para el Estudio del Dolor, Roche, Boehringer Ingelheim, LivaNova, AbbVie, GSK, Novartis, BMS, and Novo Nordisk, consulting fees from UN Office for Project Services, Inter-American Development Bank, WHO, Alliance for Health Policy and Systems Research, and UNDP, and honoraria from Merck, MSD, Grünenthal, Novartis, AbbVie, Boehringer Ingelheim, and Roche, outside of the submitted work. All other authors declare no competing interests.