Biosimilars approved in Colombia

Biosimilars/General | Posted 11/02/2022 post-comment0 Post your comment

In Colombia, the regulatory body for the approval of biologicals is the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA).

INVIMA V22B11

INVIMA is the National Regulatory Agency, a technical-scientific surveillance and control entity, which works to protect the individual and collective health of Colombians, through the application of health standards associated with the consumption and use of food, medicines, medical devices and other products subject to health surveillance.

In 2014, Decree 1782 was issued, establishing the legal framework to regulate the production and marketing of biotechnological products, and including the basis to facilitate the advent of biosimilars in the market, on concrete definitions of comparability.

To date, INVIMA has approved four biosimilars [1] within the product classes of: 1) insulin; 2) tumour necrosis factor (TNF) inhibitor; 3) follicle stimulating hormone (FSH) for use in Colombia, see Table 1.

Table 1: INVIMA approved biosimilars
Product name Active substance Therapeutic area Manufacturer/ Company name
Basaglar insulin glargine Diabetes type 1 and 2 Lilly France
Ojivri trastuzumab Early breast cancer
Metastatic breast cancer
Metastatic gastric cancer
Mylan GmbH
Prolugyn human chorionic gonadotrophin hormone Ovulation induction for infertility LG Chem Ltd
Remsima (CT-P13) infliximab Ankylosing spondylitis
Crohn's disease
Psoriasis
Psoriatic arthritis   
Rheumatoid arthritis
Ulcerative colitis
Celltrion
Data updated on 11 February 2022.
Source: INVIMA.

 

Etanar, a biomimic of etanercept, is also authorized in Colombia for use in the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.

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 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 ‘medicamentos biosimilares’ approved in Colombia 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

Similar biotherapeutic products approved and marketed in Latin America

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: Biosimilares aprobados en 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: Biosimilares aprobados en 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. 

  

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. Glosario de términos principales [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 11]. Available from: www.gabionline.net/es/biosimilares/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 © 2022 Pro Pharma Communications International. All Rights Reserved.

Source: INVIMA

comment icon Comments (0)
Post your comment
Related content
Biosimilars of pembrolizumab
Cancer image015
Biosimilars/General Posted 14/10/2022
EMA calls for biosimilar interchangeability across the EU
01 AA007239
Biosimilars/General Posted 23/09/2022
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