The traditional INN naming system for small molecule drugs has been working well without any particular concerns since 1950s. However, with the introduction of biological medicines in 1990s and subsequently biosimilars after the originator drugs become off patent, due to the ‘similar’ nature of biological and biosimilar medicines, many biosimilar medicines from different companies will enter the market for patient access. This raises the discussion on nomenclature of INNs and the naming system of biosimilar medicines, which relates to tracking and tracing of all biological including biosimilar medicines.
On top of this, different regions or countries are using different INN naming system for biosimilar medicines; there is a need to address the issue with scientific and structured information.
This editorial series offer a structured overview on the various naming systems in use, the current development and discussion if the INN naming system on biosimilars, what are the concerns/issues surrounding tracking and tracing, a summary of the latest discussion at WHO, as well as views from different stakeholders.
This editorial series aim to document these discussions for future references, and to provide clarity and background information to those involved in evaluating the biosimilars naming regulatory policy.
Dr Rafaella Balocco-Mattavelli, INN Program Director, World Health Organization, Switzerland
Dr Robin Thorpe, PhD, Deputy Editor-in-Chief, GaBI Journal, UK
For further information on the editorial topics, please contact the Publisher.