To address the issue of regulatory process of biosimilars, including intended copies*, the Americas Health Foundation (AHF) conducted a literature review and convened a panel with eight experts in biological cancer therapies and health economics to address the most salient issues concerning the regulation of biosimilars in Latin America [1].
The development of biological and biotechnological products in Latin America is remarkably diverse due to the particularities related to numerous factors such as cultural, economic, political, and regulatory factors. Each Latin American country therefore has a unique market and regulatory outlook [2]. Given this scenario, a revision of their regulatory pathways was considered.
This policy review conducted by AHF with eight-member expert panel from Colombia, Chile, Ecuador, Guatemala and Peru, was focused in five Latin American countries.
The regulatory challenges identified by the panel members 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.
The panel members developed recommendations to improve the implementation of biosimilar regulatory pathways and consistent procurement strategies to increase their access to patients mainly with breast cancer and colorectal cancer, which are the second and third most common cancers in Latin America.
Biologicals have become an integral part of breast cancer care with the arrival of trastuzumab, Similarly, biologicals are often used in advanced treatment of colorectal cancer, including antiangiogenic agents such as bevacizumab, aflibercept and ramucirumab. But perhaps the main barrier to easily getting a patient on a biological remains in their high cost and limited availability, thus biosimilars are an effective and equivalent alternative to originator biologicals, which contribute to the sustainability and financing of healthcare systems and favour access to biological therapies with the same safety, efficacy and quality as the original product.
The recommendations given in the policy review are not intended as a unified solution for the Latin American region and should be tailored on a country-by-country basis and can serve as a strategy for biosimilar adoption in other countries in a similar situation [1].
*Intended copies (also known as non-comparables, biocopies, biomimics, and non-regulated biosimilars) are copies of originators that have not undergone the stringent regulatory process for biosimilars. They are copies of already licensed biological products that have not met the requirements of the WHO, EMA, or FDA to establish biosimilarity [3].
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References
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. GaBI Online - Generics and Biosimilars Initiative. Regulation of the registration of biological drugs in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 22]. Available from: www.gabionline.net/biosimilars/research/regulation-of-the-registration-of-biological-drugs-in-latin-america
3. GaBI Online - Generics and Biosimilars Initiative. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 22]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales
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