In Uruguay, the regulatory body responsible for the approval of biologicals is the Ministry of Public Health of Uruguay (Ministerio de Salud Pública de Uruguay, MSP).
Biosimilars approved in Uruguay
Biosimilars/General | Posted 24/09/2021 0 Post your comment
The MSP is the ministry of the Government of Uruguay responsible for establishing public health policies and strategies, in order to contribute to the improvement of the health of the inhabitants of the nation.
The mission of the MSP to establish policies and strategies for the fulfilment of essential public health functions, as well as to guide the functioning of the National Integrated Health System (SNIS). It aims to contribute to developing health promotion and prevention policies, standardizing and regulating the treatment and rehabilitation of illness, under the principles of universality, equity, quality, solidarity, sustainability and efficiency.
The legal framework was established in Uruguay through Decree 38/015 of 3 February 2015 which establishes the basis for the registration of biotechnological medicines. Chapter III of Decree 38/015 establishes the basis for the registration of similar biotechnological medicines (by comparability), which lists, among others, the requirements for necessary preclinical and clinical comparative studies necessary and the way in which they should be carried out.
To date, the Ministry of Public Health has approved two biosimilar monoclonal antibodies for use in Uruguay , see Table 1.
|Table 1: Biosimilar medicines approved by the Ministry of Public Health Uruguay|
|Product name||Active substance||Therapeutic area||Authorization date||Manufacturer/ Company name|
|Not available||mAbxience, Argentina/Spain|
*Data updated on 24 September 2021.
Fuente: Ministerio de Salud Pública de Uruguay (MSP)
Two biomimics are also authorised in Uruguay:
1. Foltran, a biomimic of filgrastim for the treatment of neutropenia, by stimulating the production and release of functional neutrophils from the bone marrow
2. Novex (Tasiur), a biomimic of rituximab, for the treatment of rheumatoid arthritis, non-Hodgkin's lymphoma and leukaemia.
Biomimics are intended copies, unregulated biologicals, biocopies, which cannot be considered biosimilars unless they have been reviewed and approved by the appropriate regulatory agencies in accordance with the international guidelines provided by the World Health Organization (WHO) for the approval of biosimilars .
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘biosimilars’ approved in Uruguay might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
The biosimilars market in Latin America: a summary
LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: Compras federales de medicamentos biológicos para el cáncer en Brasil
Browse the news in the Latin American Forum!
LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de esta semana: Compras federales de medicamentos biológicos para el cáncer en Brasil
Explore las noticias en el Foro Latinoamericano!
1. Ortiz-Prado E, Ponce-Zea J, Vasconez JE, et al. Current trends for biosimilars in the Latin American market. Generics Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):64-74. doi:10.5639/gabij.2020.0902.011
2. GaBI Online - Generics and Biosimilars Initiative. Glossary of key terms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 24]. Available from: www.gabionline.net/biosimilars/general/Glossary-of-key-terms
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Source: Ministerio de Salud Pública de Uruguay (MSP)