WHO Informal Consultation on International Nonproprietary Names (INN) Policy for Biosimilar Products

To the WHO INN Expert Group

1) INNs should be based, as now, on considerations of molecular characteristics and pharmacological class. No specific process should be introduced for naming biosimilars. INNs for these products should be assigned according to the standard process for naming biologicals. There should be no change in policy and no distinctive INN designation introduced to indicate a biosimilar product.

2) An in depth review of the current policy for naming and defining biologicals should be undertaken to further ensure consistency of approach and identify anomalies. Any new policy should not be applied retrospectively.

3) Consideration should be given to new approaches to developing nomenclature for biologicals so as to better deal with future products. The simplified nomenclature system discussed for dealing with proteins and their post translational modifications should be one new proposal for consideration. Other proposals included the publication of the full 

amino acid sequence of a product together with any modifications in order to define unambiguously the product.

4) Consideration should be given to the timing of application submissions for new INNs for biologicals, and to the amount of information needed to make an informed decision on the issue.

5) The WHO INN Expert Group should develop a clear message explaining the process of assigning an INN and the intended purpose of this nomenclature, as well as its limitations for biologicals.

To the Expert Committee on Biological Standardization

6) When developing regulatory guidance for biosimilars, mention should be made of INN policy for biologicals and biosimilars. However, it should be explained that INN policy relates solely to nomenclature and that no distinctive INN designation is introduced to indicate a biosimilar product.