Calls for biosimilars to go through full HTA process
All biosimilars should be assessed by NICE, and its regional counterparts like the SMC, in the same way as their originator products, according to the ABPI.
The UK pharma industry association told PMLiVE that biosimilars should undergo “the standard full health technology assessment processes” so that they can be “appropriately assessed for clinical and cost effectiveness”.
Unlike generic versions of small molecule drugs biosimilars are based on similarity to an original product, rather than bioequivilance, a difference the ABPI is concerned will be overlooked.
The association recently released a position paper covering seven areas where it says action on biosimiliars is needed by regulators, HTA agencies, NHS commissioners and NHS healthcare professionals.
These include clinical testing, something the ABPI says should be greater than at present and it calls for all biosimilars to “demonstrate safety and efficacy through robust phase III trials in exactly the same manner as the originator medicine”.
Although the global biosimilar market is predicted to hit $18bn by 2017, regulatory guidelines have been slow in coming and where they have been issued are not always followed in clinical practice.
The ABPI cites the example of a 2008 a MHRA Drug Safety Update that recommended doctors prescribe biologics by brand name, rather than International Nonproprietary Name (INN). The aim of this was to prevent automatic substitution of a biosimilar by pharmacists, but “this has not yet been fully implemented in NHS clinical and pharmacy practice”, according to the APBI.
The ABPI's biosimilar recommendations
Download the ABPI's position paper on biosimilars