Off-patent biologicals/Biomimics approved in Bolivia

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 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.

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras

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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

Posted 07/01/2022 by Anthika U, GaBI Online Editorial Office

Response to ‘Off-patent biologicals/Biomimics approved in Bolivia’

Dear Sirs at AGEMED,
Thank you for your valuable comment received on 17/09/2021. As we specify within the article ‘Biomimics are intended copies, unregulated biologicals, biocopies, which cannot be considered biosimilars’, therefore, there is a difference made between one another and their status as being officially recognised by the relevant regulatory agencies in accordance with the international guidelines provided by the World Health Organization (WHO) for the approval of biosimilars.
We very much appreciate your kind feedback. Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online.
Best Regards, Anthika

Posted 07/01/2022 by Anthika U, GaBI Online Editorial Office

Response to ‘AGEMED has a different story to tell’

Dear HardiK Gandhi,
Thank you for your valuable comment received on 17/09/2021. We are planning on making a new article about ‘Biomimics approved in Bolivia’ with the correct and most updated information.
We very much appreciate your kind feedback. Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online.
Best Regards, Anthika

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 have 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.