Will 'clones' qualify for uptake drivers?

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Almost certainly one of the first issues to be discussed at the first meeting of the biosimilar working group including industry associations will be the status of so-called 'clones'.

More 'clones' or rebranded originators are starting to appear on the TGA's register of therapeutic goods, presumably a commercial response from companies with originator biologics facing the threat of biosimilar competition.

'Fighting' generic brands have been used by originator companies for decades, with mixed success, but the introduction of new biosimilar uptake drivers creates an interesting scenario for policy-makers.

Should 'clones' - the originator with a new brand - qualify for the uptake drivers?

The uptake drivers negotiated with the sector earlier this year were headlined by a software change that will see prescribing by international non-proprietary name (INN).

Potentially more significant for the clones is preferential prescribing of biosimilars for treatment naive patients and the loosening of prescribing authorities for biosimilars over originator biologics, based on a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC).

Will PBAC consider a rebranded originator a biosimilar for the purpose of qualifying for these uptake drivers? Or, will it exclude them, only allowing the new drivers to apply where TGA has approved a therapy as a 'biosimilar'. Yet even that is unclear because the current regulation may limit the regulator's power not to designate a 'clone' a biosimilar. Would policy-makers even want to intervene to limit competition at the level of new uptake drivers given the potential for it to benefit from price-disclosure driven reductions?