On 27 February 2025, Colombia's Ministry of Health, the National Institute of Health, and VaxThera announced a pivotal agreement to enhance research, development, and production of biologicals and health technologies. This collaboration aims to strengthen health sovereignty, advance biotechnology, and improve emergency response capabilities.
This agreement marks a key step toward self-sufficiency and advancement in the production of biotechnologies (vaccines and biologicals) in Colombia, with the following lines of action:
- Exchange and training of researchers for the development of key public health inputs.
- Promotion of research and development of joint projects across all stages of biological products life cycle.
- Transfer of technology and knowledge among cooperating and strategic partners.
- Strengthening human talent in science, technology, and innovation for vaccine development.
- Implementation of strategies to improve vaccination in Colombia.
- Identification and local production of priority biological products in the short, medium, and long term.
The agreement also seeks to improve local and inter-institutional capacity to address health emergencies and public health events by establishing long-term scientific, technical, and technological cooperation. This will foster the development of the national biotechnology sector and strengthen the response to health crises.
This public-private collaboration not only improves the capacity to respond to health emergencies but also contributes to building a stronger, more innovative, and sustainable health system for the country.
In 2014, the Colombian Ministry of Health issued Decree Number 1782 of 2014, which defined the requirements for the sanitary registration of new (pioneer) and known (biocompetitors, biosimilars or biogeneric) biological medicines, establishing three approval routes: a full dossier route for originator biological medicines and two routes for biosimilars (the comparability route and the abbreviated comparability route), all of which include immunogenicity testing [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Regulatory landscape for biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 7]. Available from: www.gabionline.net/biosimilars/research/regulatory-landscape-for-biosimilars-in-latin-america
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