In this interview, Dr Fermin Ruiz de Erenchun explains how access to biotherapeutic products, including biosimilars, and ensuring their quality, safety and efficacy will be important challenges in the future, namely in Latin America. Science-based regulatory standards for medicines, in alignment with World Health Organization (WHO) guidance, are essential to ensure patient safety, and implementation of these standards at the national level will be critical moving forward.
Biotherapeutics are typically derived from living organisms. They are made by genetically engineering DNA, and a high level of precision is required in the commercial manufacturing process to produce a consistent product each time. Every step we take in the production of these medicines requires highly controlled testing to ensure consistent quality, safety, and efficacy.