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Biomedicines

Volume 486: debated on Monday 12 January 2009

To ask the Secretary of State for Health (1) what recent discussions there have been between the National Institute for Health and Clinical Excellence and specialist clinicians on future appraisals of biosimilar medicines; and if he will make a statement; (246079)

(2) what guidance his Department has issued to the National Institute for Health and Clinical Excellence (NICE) on the safety precautions to be reflected in NICE guidances on biosimilar medicines; and what account NICE takes of the safety precautions recommended by the Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency in formulating such guidance.

The National Institute for Health and Clinical Excellence (NICE) is an independent body and should be approached directly for information on any recent discussions with specialist clinicians.

We have not issued any guidance to NICE on the appraisal of biosimilar medicines. Any relevant advice from the Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency will be taken into account by NICE in its work.