WHO to update naming of biotech medicines such as biosimilars

The World Health Organisation (WHO) is moving ahead with plans to update the International Non-proprietary Name (INN) conventions for biotechnology-derived medicinal products, including biosimilars.

At an WHO open meeting held this month in Geneva, it was discussed whether biologics produced by different manufacturers should be given the same or a distinct INN (International Non-proprietary Name) as compared to the innovator product.

As INNs play a key role in prescribing and dispensing of medicines in WHO member countries, a new policy may have a significant impact.

According to the European Biopharmaceutical Enterprises (EBE), a distinct INN for each biotech medicine or biosimilar would facilitate the traceability of adverse events and impose some restrictions on inappropriate automatic substitution by biosimilars. This method would therefore address some safety concerns raised in a joint EBE and the European Federation of Pharmaceutical Industries (EFPIA) technical position paper last July.

Conclusions at the WHO open meeting were that the current INN system is useful and efficient but there are some inconsistencies in naming conventions for a few biotech products leading to possible confusion.

The WHO INN committee hopes to come up with a new proposal in the future that would take into account the views expressed by regulators and industry at the recent open meetings.

Representatives at the meeting included the Innovative Pharmaceutical and Biotechnology Industry Trade Associations, the Generic Pharmaceutical Manufacturers' Associations as well as observers from the European Commission, EMEA and FDA, the Pharmacopoeia.

The EBE-EFPIA technical position paper can be found at: http://www.ebe-bio-pharma.org/docs/pdf/Biosims_EBEEFPIAPosition_Naming_7July2006.pdf