An increasing number of biological medicines are being developed and used to treat a wide range of health conditions, such as cancers, diabetes, autoimmune diseases. Many challenges impede wider use of these technologies by patients and national health systems, including their high prices. Out of the 10 most sold medicines in 2017, 7 are biologics. Complexities in the development, production and regulatory framework for biologics can limit competition, contributing to keeping prices out of reach for many. With patent protection and data exclusivity for a number of biologics medicines expiring, how can regulations assure quality, safety and efficacy, without becoming a technical barrier to competition? How can regulation accelerate access?

Carolina Gomez will present the regulation Colombia adopted in 2014 for the evaluation of biologics, with a special focus on the process to authorize competing products -- i.e. biosimilars or biogenerics. She will explain the ‘fast-track’ approach used to accelerate access by reducing unnecessary regulatory requirements, as detailed in her 2016 article. She will also identify the main technical barriers in the international regulation of biologics (e.g. clinical comparability, differential nomenclature and restriction of substitution and interchangeability) explored in her forthcoming paper. Finally, she will discuss how the regulation adopted in Colombia can inform ongoing international debates, including the evolution of WHO guidance on biologics regulation.

Carolina Gomez is an advisor for the General Directorate, INVIMA - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Institute of Food and Drug Monitoring), Colombia.