Biosimilars as a sustainable alternative for complex diseases

Biosimilars/General | Posted 23/07/2021 post-comment0 Post your comment

The use of ‘similar biotherapeutic’ products and ‘biocomparable’ medicines, as biosimilar medicines are named in Colombia and Mexico, respectively, offer a sustainable alternative for health systems, leading to significant savings for payers and health institutions, as well as market opening. Biosimilars thus provide a fair competitive solution.

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There are currently 13 biocomparables approved in Mexico in the following therapeutic classes: 1) erythropoiesis stimulating agent; 2) granulocyte colony stimulating-factor (G-CSF); 3) endogenous growth hormone; 4) follicle stimulating hormone (FSH); 5) insulin; 6) tumour necrosis factor (TNF) inhibitor; 7) antivirals and interferon.

In Colombia, according to the Ministry of Health and Social Protection, out of 10 of the most reimbursed drugs in the health system, eight are of biological origin and are mainly intended to treat complex diseases. Furthermore, by having at least two competitors for each of the eight most reimbursed drugs, the system could free up resources of approximately Pesos 600,000 million, so the entry of biosimilars into the country represents an important contribution to the financial sustainability of the healthcare system.

Gianfranco Biliotti, General Manager of Amgen in Colombia stated that the introduction of biosimilars into the healthcare system helps to put resources into other areas such as innovation, new therapies and even infrastructure. Likewise, Dr Max Saráchaga of Amgen Mexico stated that ‘at the heart of Amgen's commitment to biosimilars is our mission to serve patients. Amgen's biosimilars will offer more treatment options for serious diseases such as cancer, bringing cutting-edge biotechnology in these areas and backed by more than four decades of experience’.

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 ‘productos bioterapeúticos similares’ approved in Colombia and ‘biocomparables’ approved in Mexico 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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The biosimilars market in Latin America: a summary

Amgen on both sides of the biosimilar arena

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Recommendations for similar biotherapeutic products published by Latin American MS experts 


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: ¿Qué conduce a las percepciones negativas de los biosimilares?

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.


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: ¿Qué conduce a las percepciones negativas de los biosimilares?

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. 

1. GaBI Online - Generics and Biosimilars Initiative. Biocomparables aprobados en Mexico []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 9]. 

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