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).
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 [1], see Table 1.
| Table 1: Biosimilar medicines approved by the Ministry of Public Health Uruguay
|
| Product name
|
Active substance
|
Therapeutic area
|
Manufacturer/ Company name
|
| Bevacizumab bioéticos
|
bevacizumab
|
Breast cancer
Colon cancer
|
mAbxience, Argentina/Spain
|
| Rituximab bioéticos
|
rituximab
|
Leukaemia
Non-Hodgkin lymphoma
Rheumatoid arthritis
|
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 [2].
Editor's comments
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.
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References
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)
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