WHO issues draft proposal for biosimilar naming

August 7, 2014 9:39 AM

A long debate is ongoing about biosimilar naming around the world. Although EU accepted the same INN system years ago, with the latest developments around the world, biosimilar naming uncertainty is still ongoing.

The global INN (International Non-Proprietary Name) system is managed by the World Health Organization. They have held several meetings to solve this long debate and finally released a proposal for biosimilars naming.

Pharma giants which are on the original, brand-name drug makers side, want biosimilars to have a unique INN in order to distinguish the medicines from the original biologics. They state that, different INNs will make it easier to track possible adverse events around the globe.

On the contrary, the biosimilar developers believe that a new naming system would certainly create a confusion for patients, pharmacists and physicians. All the stakeholders will have difficulty to understand the similarity of these products and verifying the dosage will be a problem.

Under this circumstances, WHO suggests that, the current system for choosing INNs remain unchanged, but that a four-letter code would be attached at the end of every drug name. The WHO says the approach, would be voluntary. Individual regulatory agencies in each country could choose whether to adopt such coding.

In a statement, Biotechnology Industry Organization (BIO) of U.S. was pleased with the recommendations. BIO president said that, “we applaud the World Health Organization for recognizing this need by issuing “Biological Qualifier: An INN Proposal,” and we strongly support its intent to ensure that all biological medicines are distinguishable.”

The proposal which is waiting for comments till September 19, 2014 can be found here.

 

Source: WHO & BIO

 

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