Biosimilars: what's in a name?

TGA

Biosimilars are not necessarily bioequivalent to the original reference product.

The WHO has recently agreed to develop a voluntary global nomenclature scheme for naming biological products to help identify biosimilars from the reference product and prevent the multiplication of biological names and naming policies.

The scheme proposes that the biosimilar be identified by glycoform profile, manufacturer and place of manufacture through use of an international non-proprietary name (INN) and a biological qualifier (BQ).

As a result the Therapeutic Goods Administration will not be continuing with the previously proposed naming convention for biosimilars while a review of the policy is undertaken.

For more details, go to: http://www.nps.org.au/publications/health-professional/health-news-evidence/2015/naming-biosimilars?utm_source=nps-direct&utm_medium=email&utm_campaign=2015-2-iss28&hq_e=el&hq_m=699258&hq_l=22&hq_v=1719f75d70

Michael Wonder

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Michael Wonder

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