GNL 29: Biosimilars and naming duplicates

The use of the centralised procedure for the authorisation of biosimilars has posed challenges, especially where the patent for the original biosimilar compound has expired, but there is patent protection for a second medical use of that compound. Under the centralised procedure there is no mechanism to remove the patented indication from the Summary of Product Characteristics or Patient Information Leaflets for those countries where that use is protected. Therefore, where the manufacturer of a biosimilar wishes to launch in those countries where the second medical use is patent protected, it must submit a duplicate application with the necessary carve out. This note explains that although this may overcome the issue of the carve out, it in turn creates the need for a separate name.

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