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. This article gives a summary of the biosimilar regulatory status for the countries represented by members of the panel of experts of the American Health Foundation (AHF). The countries reviewed are Chile, Colombia, Ecuador, Guatemala and Peru .
In the early 2000s, Latin America had around 100 biological products on the market that were intended copies* of originator products and registered as generics. But it was in 2010 when countries in Latin America started distinguishing between the approval process for generics and biopharmaceuticals .
Although the trend is to increase regulatory standards for the health registration of biosimilars in Latin America, regulations are still heterogeneous and vary considerably from one country to another . Given that, a revision of the region’s regulatory pathways was needed to ensure that efficient and streamlined processes do not compromise safety assessments.
Each country should create a specific regulatory pathway for biosimilars that differs to the approval pathway for generic drugs and biological originators. These pathways should be based on the recommendations provided by the World Health Organization (WHO) or the processes already implemented by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
According to the expert panel members, Teran et al., this is the regulatory pathway for biosimilars in the five Latin American countries represented by members of the panel :
In 2011, Chile’s Agencia Nacional de Medicamentos (ANAMED) of the Institute of Public Health, announced the draft guidance for the evaluation of biosimilars in Chile. The Ministry of Health issued Technical Guideline Number 170 in 2014, approved by Decree Number 945 of 2014 (and its amendments), which outline the regulations for the biosimilar registration pathway (TG Number 170). According to the guideline, the approval process is based on a standalone procedure, which includes submission of preclinical and clinical trials [1, 4].
In 2014, Colombia’s Ministry of Health issued Decree Number 1782 of 2014, in which the requirements for the health registration of new (pioneering) and known biological (biocompetitors, biosimilars, or biogenerics) drugs were defined, by establishing three approval pathways: a complete dossier route for originator biological drugs and two routes for biosimilars (the comparability route and the abbreviated comparability route), all of which include immunogenicity tests . The abbreviated route allows pharmaceutical companies to use available information on safety and efficacy of a product without the need to expose animals and humans to unnecessary experiments .
A specific regulation for the approval of biosimilars has existed since 2013. It was further modified in 2019 (Acuerdo Ministerial Número 00385-2019 issued by the Ministry of Public Health), to be aligned with international guidelines. The main challenge is providing free homologation for products already approved in other countries, some of which do not meet best practices .
In 2019, the Ministry of Public Health adopted Normativa 67-2019 for the approval of biologicals, biotechnology and biosimilars. This pathway allows the extrapolation of biosimilars approved by FDA, EMA, and recommended by WHO. The main challenge is that Guatemala does not have a strong mechanism for pharmacovigilance .
In 2011, the Peruvian health authorities established separate regulations for pharmaceutical drugs, i.e. chemically synthesised, and biotechnology drugs. In 2016, the Supreme Decree Number 013-2016-SA was released. This regulation is intended to give more specific requirements for biologicals and biosimilars, and to complement the general requirements covered in Supreme Decree Number 016-2011-SA . The approval of biosimilar drugs requires the filing of additional documents such as the comparison with the originator according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. This pathway allows the extrapolation of biosimilars approved by FDA and EMA, and recommended by WHO .
The development of biological products in Latin America is 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 , but changes to strengthen and harmonise national regulations across the region with international standards might enable more accurate approvals and effective processes than those currently in place.
*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 WHO, EMA, or FDA to establish biosimilarity .
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1. Teran E, Gomez H, Hannois D, et al. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. Lancet Oncol. 2022;23(7):e348-e358.
2. Feijó Azevedo V, Mysler E, Aceituno Álvarez A, et al. 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
3. GaBI Online - Generics and Biosimilars Initiative. Regulations of the registration of biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from: www.gabionline.net/biosimilars/research/regulations-of-the-registration-of-biosimilars-in-latin-america
4. GaBI Online - Generics and Biosimilars Initiative. Proposed biosimilar guidelines in Chile [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from: www.gabionline.net/guidelines/Proposed-biosimilars-guidelines-for-Chile
5. Sierra Esteban FJ, García Cortes JA. Regulations for biotherapeutics approval in Colombia. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):26-8. doi:10.5639/gabij.2018.0701.006
6. GaBI Online - Generics and Biosimilars Initiative. Nomenclature of biologicals and biosimilars in Peru [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from: www.gabionline.net/policies-legislation/nomenclature-of-biologicals-and-biosimilars-in-peru
7. 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 Sep 9]. Available from: www.gabionline.net/biosimilars/research/regulation-of-the-registration-of-biological-drugs-in-latin-america
8. GaBI Online - Generics and Biosimilars Initiative. Glosario de términos principals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 9]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales
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