Nomenclature
International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. Biological active substances now comprise more than 40% of applications to the INN Programme and the percentage is increasing. An inventory of the policy decisions taken by the INN Expert Group, and of the names assigned to biological and biotechnological substances, are available at:
Of specific potential interest to biosimilar products, a Biological Qualifier scheme has been proposed to provide a uniform global means of identification of the active substance for a biological product that was assigned an INN. This would avoid the proliferation of separate and distinct schemes developed by individual regulatory authorities and assist in the prescription and dispensing of biosimilars.