In Paraguay, the regulatory body responsible for the approval of biological drugs is the National Directorate for Sanitary Surveillance (Dirección Nacional de Vigilancia Sanitaria, DINAVISA).
The mission of DINAVISA is to guarantee the fulfillment of the functions of stewardship, management, financing and provision of health services, with the aim to reach universal coverage, under the approach of social protection, within the framework of the National System of Health.
On 29 December 2016, the legal framework for the requirements and guidelines for the Sanitary Registry of biosimilar medicines by comparability was stablished through Chapter IV of the Decree 6611 by which Article 24 of Law N 1119/1997 is regulated, ‘On health products and others’, and the requirements for the registration of biological medicines are established.
DINAVISA defines similar biological medicine or biosimilar as a biological medicine that demonstrate similarity in terms of safety, quality, efficacy and immunogenicity to the reference biological medicine through the established comparability exercise.
To date, DINAVISA has approved two monoclonal biosimilar antibodies [1] for use in Paraguay, see Table 1.
| Table 1: Biosimilars approved by DINAVISA
|
| Product name
|
Active substance
|
Therapeutic area
|
Manufacturer/
Company name
|
| Bevacizumab Bioethics
|
bevacizumab
|
Breast cancer
Colon cancer
|
mAbxience
|
| Rituximab Bioethics
|
rituximab
|
Rheumatoid arthritis
Leukaemia
Non-Hodgkin's lymphoma
|
mAbxience
|
Data updated on 15 October 2021.
Source: DINAVISA
|
Two biomimics of rituximab for the treatment of rheumatoid arthritis, leukemia and non-Hodgkin lymphoma are also approved in Paraguay:
1. Novex (Tasiur)
2. Reditux/Tidecron
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 Paraguay 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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| 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: Posible colaboración biotecnológica entre India y Colombia Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. 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: Posible colaboración biotecnológica entre India y Colombia Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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Reference
1. Ortiz-Prado E, Ponce-Zea J, Vasconez JE, Castillo D, Checa-Jaramillo DC, Rodrí¬guez-Burneo N, Andrade F, Intriago-Baldeón DP, Galarza-Maldonado C. 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. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 15]. Available from: www.gabionline.net/es/biosimilares/general/glosario-de-terminos-principales
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