WHO TRS (Technical Report Series) 948, 2008 Annex 5

WHO TRS (Technical Report Series) 948, 2008 Annex 5

International Nonproprietary Names for biological and biotechnological substances: a review


More than 50 years ago, WHO established the International Nonproprietary Name (INN) Expert Group/WHO Expert Committee on Specifications for Pharmaceutical Preparations, to assign nonproprietary names to medicinal substances, so that each substance would be recognized globally by a unique name. These INNs do not give proprietary rights, unlike a trademark, and can be used freely as they are public property.

INNs have been assigned to biological products since the early days of the INN Programme. As well as many names for individual substances, animal insulin preparations were given an INN in Recommended list 3 in 1959. In the period up to 1980, names were assigned to antibiotics, synthetic peptides, hormones and other proteins. In names of compounds related by structure and/or function, specific letter groups, called stems, are included to aid recognition by health professionals. The -actide synthetic corticotrophin analogues is an example.

In 1982, the name insulin human was proposed for the recombinant protein identical to natural human insulin and since then names have been assigned to a growing number of recombinant products. Within the INN Programme, names have not been assigned to natural human blood products or vaccines. For those groups of biological products the WHO Expert Committee on Biological Standardization (ECBS) has been adopting the scientific names of the biological products within the definitions of respective requirements.

Since the time that insulin human became the first recommended INN (rINN) for a recombinant product, the range of biological/biotechnological products has increased in size and complexity. For example, new stems have been introduced for tissue plasminogen activators (-plase) among other groups. Analogues of recombinant glycosylated proteins produced in different cell systems have been classified using Greek letters as indicators in the sequence of product introduction: erythropoietin (epoetin alfa, beta and so on) and glycoprotein hormones (follitropin) are examples. In the 1990s, a systematic scheme for naming monoclonal antibodies was implemented, based on the stem -mab, which indicates the origin (mouse, human, etc.) of the antibody and its intended use: tumour, immunomodulator and so on.

As a result of the scientific and technical developments currently taking place, new products of biotechnology and other biological products are being introduced and more products can be expected for the treatment or prevention of disease. Examples of such new products include recombinant blood products, transgenic products (human proteins expressed in animals or plants), products for gene therapy and novel vaccines.

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WHO TRS (Technical Report Series) 948, 2008 Annex 5:

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