The biosimilar regulatory scenario is very diverse and varies widely in the large group of Latin American countries. Authors Teran et al. presented some recommendations for making biosimilar regulations in Latin America more homogeneous and comprehensive .
As the regulatory landscape of biosimilars in Latin America continues to develop, translating into practice the recommendations defined by regulatory agencies is necessary.
Although the analysis of the Latin American expert panel Teran et al. used biosimilars for treatment of breast cancer and colorectal cancer as a case study, they identified issues and provided recommendations that are focused on biosimilar regulations and relevant for all biosimilar products regardless of their cancer target. These recommendations are :
1. Adapt to international standards
Regulatory pathways for biosimilars should be updated according to international standards on the basis of the recommendations provided by World Health Organization (WHO) or the processes already implemented by the US Food and Drug Administration (FDA) or the European Medicines Agengy (EMA). Biosimilars do not require local completion of extensive phase III and phase IV clinical studies and can be approved on the basis of non-inferiority evidence alone. However, expanding the role of pharmacokinetic and analytical studies of these compounds is crucial.
Responsible stakeholders are: governments, regulatory agencies, academia, medical societies, non-governmental organizations (NGOs), manufacturers, and healthcare providers.
To ensure that a biosimilar coming onto the market has the same clinical safety and efficacy as the original product, regulatory agencies need to establish well-designed pathways to achieve approval .
2. Standardise regulatory pathways throughout the region
Implement strategies to harmonise biosimilar regulations by leveraging the initiatives already in place. The strategies include establishing a regional position through a space for regulatory convergence, where different drafts of WHO guidelines are disseminated and discussed; training and experience exchange between different local regulators; and regional cooperation in terms of cost, processes expediency, and accuracy of approvals.
Responsible stakeholders: governments, NGOs, and regulatory agencies.
Extrapolation of approvals from agencies such as the EMA or US FDA should be considered by Latin American regulatory authorities when no substantial clinical differences between the biosimilars and the original compounds are found and biosimilarity is established. Extrapolation reduces or eliminates the need for repeating local and indication-specific clinical studies that have established the safety and efficacy of the originator product.
Responsible stakeholders are: governments, regulatory agencies, academia, medical societies, NGOs, and health-care providers.
4. Separate pathways for biosimilars
Implement a specific pathway for biosimilars that is different from the approval pathways for generic drugs and biologic originators.
Governments, regulatory agencies and NGOs are the stakeholders involved.
5. Invest in training and expanding human resources
Invest in educational programmes for regulatory personnel. Because the biosimilar approval requires specific regulations, people in charge of reviewing applications must be specifically trained for this purpose. Establishing regional working groups to assist national regulatory authorities in biosimilar approval could be useful.
Responsible stakeholders are governments, regulatory agencies, academia, medical societies, manufacturers and healthcare providers.
Implement a naming convention to clearly identify and differentiate between biosimilars and originators.
Governments, regulatory agencies, and manufacturers are responsible stakeholders.
7. Implementation and adherence
Once implemented, adherence to these regulations is of upmost importance. Adequate implementation of biosimilar regulations requires concerted efforts by all stakeholders to overcome organisational, normative, and information technology challenges.
Responsible stakeholders: governments, regulatory agencies, academia, medical societies, NGOs, manufacturers and healthcare providers.
Latin America faces continuously increasing cancer expenditure, partly as a consequence of the COVID-19 pandemic; thus, there is an immediate need to streamline regulatory processes to allow for more biosimilars to reach the population for whom they were developed .
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LATIN AMERICAN FORUM
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1. Teran E, Gomez H, Hannois D, Lema M, Mantilla W, Rico-Restrepo M, McElwee E, Castro Sanchez N, Valdivieso N, Espinoza MA. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. Lancet Oncol. 2022 Jul;23(7):e348-e358. doi: 10.1016/S1470-2045(22)00121-8. PMID: 35772466.
2. Azevedo VF, Mysler E, Aceituno Álvarez AA, Hughes J, Flores-Murrieta FJ, Ruiz de Castilla EM. Recommendations for the regulation of biosimilars and their implementation in Latin America. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):143-8. doi:10.5639/gabij.2014.0303.032
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