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Biosimilars should be routinuely assessed by NICE, says ABPI

Calls for biosimilars to go through full HTA process

ABPI London offices

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

  • All biologic/biosimilar prescriptions should be written by brand name and not by International Nonproprietary Name (INN)
  • A biologic or biosimilar must only be substituted with the knowledge and consent of the treating physician
  • Patients should be kept fully informed about their medication and should be consulted if any changes to their treatment are made
  • The summary of medicinal product characteristics (SmPC) should clearly indicate the source of information contained within it, such as relevant clinical studies or that it has been derived from evidence about the originator product
  • Biosimilar medicines should be subject to full Health Technology Assessment processes in the UK
  • Tenders which are undertaken involving biosimilar medicines should not seek to source a single product only.
  • There should be no automatic indication extrapolation for biosimilar products

Download the ABPI's position paper on biosimilars

3rd December 2012

From: Regulatory

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