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Appraisal of biosimilar medicines, cell therapies and gene therapies

Position statement for biosimilar medicines

AWMSG does not usually appraise biosimilar medicines.

Existing health technology assessment (HTA) advice for the ‘reference’ medicine, published by AWMSG or the National Institute for Health and Care Excellence (NICE), will automatically apply for biosimilar medicines licensed for the same indication and in the same population as the ‘reference’ medicine. Without advice for the ‘reference’ product, a biosimilar medicine is not endorsed for use within NHS Wales.

The marketing authorisation holder of the ‘reference’ or biosimilar medicine is encouraged to engage with AWMSG when there is negative HTA advice or in the absence of advice. Please refer to the AWMSG process for industry engagement (PDF, 477Kb) for further information.

AWMSG reserves the right to request a submission for appraisal of any biological medicine, when directed by the AWMSG Steering Committee.

Position statement for cell therapies and gene therapies

We expect that the majority of cell therapies and gene therapies will appraised by NICE. With the exception of those cell and gene therapies submitted for appraisal by NICE,  AWMSG will appraise cell and gene therapies for patients living in Wales if the therapy has been classified as a medicinal product.

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