In a review by Machado et.al., the authors examine the transparency and guidelines for biosimilars licensing and the number of biosimilars approved by 13 medicines regulatory authorities. In this context, we focused the discussion on seven Latin American countries: Argentina, Brazil, Chile, Colombia, Guatemala, Mexico and Peru as part of the broader review [1].
The biosimilar regulatory situation in Latin America varies broadly among the different countries, even though Latin America is moving towards consolidating defined and standardised regulatory pathways for these products [2].
Terminology and definitions of biologicals are an important element to harmonized within the different regulatory authorities globally.
Table 1 provides information on the terminology, definitions adopted and the year when regulations were issued. Regulatory authorities implemented regulatory guidelines for the registration of biosimilars from 2010 to 2016. There was a convergence in terminology and the term ‘biosimilar’ was adopted by two regulatory authorities: Chile and Guatemala. ANMAT (Argentina) and INVIMA (Colombia) did not implement a specific term to identify biologicals approved upon demonstration of similarity to a reference product.
Table 1: Biosimilar terminology and definition in seven Latin American regulatory authorities
| Country
|
Regulatory authority
|
Terminology
|
Definition
|
Year
|
| Argentina
|
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
|
No specific terminology
|
Medicinal specialties of biological origin whose qualitative and quantitative composition, therapeutic indication and proposed route of administration, have a history in other medicinal specialties of biological origin authorized and registered with ANMAT or another regulatory health authority (Ministerio de Salud and Administración Nacional de Medicamentos, Alimentos y Tecnologia Medica, 2011).
|
2011
|
| Brazil
|
Agência Nacional de Vigilância Sanitária (ANVISA)
|
Biological product developed by comparability pathway
|
Biological product which approval was based on a comparability exercise demonstrating similar quality, efficacy and safety to a reference biotherapeutic product (Brasil, 2010).
|
2010
|
| Chile
|
Instituto de Salud Pública de Chile (ISP Chile)
|
Biosimilar
|
Biotechnological medicine that has demonstrated to be comparable in terms of quality, safety and efficacy in relation to a reference biotechnological product, based on exhaustive characterization through comparability studies conducted in equal conditions, including quality, non-clinical and clinical studies, all of them comparative (República de Chile and Ministerio de Salud, 2014)
|
2014
|
| Colombia
|
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
|
No specific terminology
|
Biological medicines that have presented the results of a comparability exercise demonstrating that the biological is highly similar to a reference product (Ministerio de Salud y Protección Social, 2014)a.
|
2014
|
| Guatemala
|
Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA)
|
Biosimilar
|
Biological/biotechnological medicine that have proved to be similar or comparable in terms of quality, safety, efficacy and immunogenicity to a reference medicine (Gobierno de Guatemala and Ministerio de Salud Pública e Asistencia Social, 2020).
|
2011
|
| Mexico
|
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
|
Biotechnology medicines biocomparable
|
The non-innovative biotechnological medicine that proves to be biocomparable to the reference biotechnological medicine in terms of safety, quality and efficacy based on the assessments established by the Law, the Regulation of Health Products and other applicable regulations (Estados Unidos Mexicanos and Presidencia de la Republica, 2021).
|
2012
|
| Peru
|
Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)
|
Similar biologic product
|
Product that is similar to the reference products in terms of quality, efficacy and safety (Gobierno del Estado Peruano and Ministerio de Salud, 2016).
|
2016
|
| aINVIMA regulation established an abbreviated comparability route in which last generation analytical techniques are required to demonstrate similarity to a RP.
Year refers to the year in which biosimilar licensing guidelines were issued
RA: Regulatory authority
|
All the regulatory authorities published guidelines for licensing of biosimilars presenting definitions aligned with the concept of the World Health Organization.
Related articles
Regulations of the registration of biosimilars in Latin America
Regulation of the registration of biological drugs in Latin America
References
1. Machado FLDS, Cañás M, Doubova SV, Urtasun MA, Marín GH, Osorio-de-Castro CGS, et al. Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison. Regul Toxicol Pharmacol. 2023 Sep 1;144:105485. doi: 10.1016/j.yrtph.2023.105485.
2. GaBI Online - Generics and Biosimilars Initiative. Regulatory landscape for biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 5]. Available from: www.gabionline.net/biosimilars/research/regulatory-landscape-for-biosimilars-in-latin-america
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