EGA calls to maintain the current robust WHO INN system

November 1, 2013 10:03 AM

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During last week’s WHO Consultation on International Non-proprietary Names (INN) Open Session to Stakeholders, Joerg Windisch, Chief Science Officer, Sandoz Biopharmaceuticals and Chair of the European Biosimilars Group- EGA Sector Group, highlighted the major contribution that has been made by the WHO to global public health by harmonising active substance naming internationally.

He also shared the EGA’s concerns that the current robust WHO INN system runs the risk of being dismantled by the discussion around biosimilar medicines. To prevent this from happening, he stressed that all biosimilar products should be assigned the same INN as their reference products. Proposals to introduce a new naming convention with different INNs will create confusion, are likely to compromise patient safety and will limit patient access to biologics. Furthermore, a new convention that discriminates against biosimilar medicines will also impact the realisation of substantial cost-savings.

EU legislation requires product identification for biological medicines through the recording of brand name and batch number. High levels of traceability and pharmacovigilance accuracy have been achieved where biosimilar and reference medicines share the same INN.

The EGA believes that the unique product brand name is the best unique identifier for patients and healthcare professionals. Also, in contrast to the INN, the brand name is simple, easy to remember, and evaluated by the EMA to ensure it cannot be confused with the name of another product. Therefore, the EGA recommends that brand names continue to be used for all biologics.

Should some countries choose not to allow the use of brand names in the prescription of biologics, a different INN would still not be required. Instead, in those countries, a new product identifier could be introduced by the WHO which should:

·         Be distinct and clearly separated from the INN
·         Be non-discriminatory and apply to all biological medicines, including biosimilar medicines and their reference products
·         Be applied retrospectively to all biological medicines

Biosimilar medicines have been used safely since 2006, and pharmacovigilance data shows that current tracking and adverse event reporting systems work well. The EU pharmacovigilance legislation as well as the recent European Commission Implementing Directive laying down measures to facilitate the recognition of medical prescriptions issued in another Member State provide a very robust framework for clear and unambiguous identification of all biologicals. Consequently, no change is necessary as regards the naming of biosimilar products”, concluded Suzette Kox, EGA Senior Director Scientific Affairs and Coordinator of the European Biosimilars Group- a Sector Group of the EGA.

 

Source: EGA press release

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