Off-patent biologicals/Biomimics approved in Bolivia

Biosimilars/General | Posted 17/09/2021 post-comment2 Post your comment

In Bolivia, the regulatory body for the approval of biologicals is the State Agency for Medicines and Health Technologies AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud).

AGEMED V21I17MN

AGEMED was created by Supreme Decree 2905 of 21 September 2016, as a decentralized unit of the Ministry of Health, with administrative, financial, legal and technical management independence, responsible for regulating the activities carried out by natural and legal, private, community, public, mixed and cooperative persons in the medicines and health technologies sector.

Until today, no biosimilar medicines have been approved in Bolivia.

Currently, three biomimics have been approved in Bolivia. These are biomimics of the monoclonal antibody rituximab, see Table 1.

Table 1: Biomimics approved by AGEMED*
Product name Active substance Therapeutic area Authorization date Manufacturer/ Company name 
Interdum rituximab Non-Hodgkin's lymphoma Not available Biocad/SAC
Reditux/ Tidecron rituximab Leukaemia
Non-Hodgkin's lymphoma
Rheumatoid arthritis
Not available Not available
Usmal rituximab Leukaemia
Non-Hodgkin's lymphoma
Rheumatoid arthritis
Not available Not available
*Data updated on 17 September 2021.
Source: AGEMED.

  
Biomimics are intended copies, unregulated biologicals, biocopies, which cannot be considered biosimilars unless they have been reviewed and approved by the relevant regulatory agencies in accordance with the international guidelines provided by the World Health Organization (WHO) for the approval of biosimilars [2].

Editor’s comment
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 ‘off-patent biologicals/biomimics’ approved in Bolivia 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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Reference
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. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: www.gabionline.net/biosimilars/general/glosario-de-terminos-principales

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Source: AGEMED

comment icon Comments (2)
Post your comment
Posted 17/09/2021 by AGEMED
Off-patent biologicals/Biomimics approved in Bolivia BIOSIMILARS/GENERAL | Posted 17/09/202

Regarding this publish, i believe that the term biomimic is a marketing word designed for pharmaceutical industry, to damage reputation or obtain monopolistic position against of market biosimilars, the authors must have care in use this term due to hve a little support in evidence and more if its creators had clear conflicts of interest

Posted 17/09/2021 by HardiK Gandhi
AGEMED has a different story to tell

AGEMED website shows several biologicals and biosimilars approved in Bolivia. Some facts in the above article do not align with the data available on the AGEMED website.

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