WHO has undertaken important actions that will promote better access to biosimilar insulins and medical devices for diabetes care. A year ago, WHO published a report, Keeping the 100-year-old promise: making insulin access universal. The report outlines how, despite the wishes of the discoverers of insulin, access to insulin and associated devices, still remains limited in many countries today. The report outlines the many barriers to access and proposes actions to address them.
Those actions include: improving the availability of human insulin and insulin analogues, especially biosimilar products; enhancing the affordability of human insulin and insulin analogues; addressing access problems associated with devices to support the appropriate use of insulins; building capacity and investing in infrastructure to support access to insulins; and supporting R&D.
Facilitating product assessment and national registration of biosimilars
WHO published revisions to the guidelines on the evaluation of similar biotherapeutic products which was adopted by the WHO Expert Committee on Biological Standardization in April 2022. The update includes the possibility of reducing the amount of data needed for regulatory approval for similar biotherapeutic products.
Facilitating selection and procurement of biosimilars
At its 23rd meeting, the WHO Expert Committee on the Selection and Use of Essential Medicines discussed the importance of reducing uncertainties about the use of biosimilars for increasing access to effective biological medicines including the need for strategies to promote interchangeability at the procurement and clinical level. The Committee thus recommended that quality-assured biosimilars, including insulin, should be considered interchangeable.
Facilitating selection and procurement of glucometers
WHO has published the WHO List of Priority Medical Devices for management of cardiovascular diseases and diabetes to support the selection and procurement of quality-assured glucometers and other medical devices for diabetes care. WHO has also published technical specifications for glucometers. These publications aim to support healthcare providers to implement essential interventions for the detection and management of diabetes across the continuum of care.