Off-patent biologicals/Biomimics approved in Bolivia

Biosimilars/General | Posted 17/09/2021 post-comment4 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.

Related articles
The biosimilars market in Latin America: a summary

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras

Similar biotherapeutic products approved and marketed in Latin America

LATIN AMERICAN FORUM

The brand-new section 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: Requisitos de certificación de BPF en Argentina, Brasil y México

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: Requisitos de certificación de BPF en Argentina, Brasil y México

Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

  
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

Source: AGEMED

comment icon Comments (4)
Post your comment
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.

Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010