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.

Related articles
The biosimilars market in Latin America: a summary

Amgen on both sides of the biosimilar arena

Amgevita approved in Colombia

Recommendations for similar biotherapeutic products published by Latin American MS experts 

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

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.