The UK’s National Institute for Health and Clinical Excellence (NICE) has published final guidance that approves the use of Sandoz Biopharmaceutical’s Omnitrope, the first biosimilar to receive official recommendation in the UK.
Biosimilars are follow-on biopharmaceuticals that are biologically similar to an existing medicine, for which a patent has expired.
The guidance issued by the NICE Appraisal Committee noted that head-to-head trials submitted as part of the regulatory submission to the European Medicines Agency (EMA) found that there were no differences in terms of safety or efficacy between the products.
Biosimilars are generally lower priced than the reference product, partly reflecting the fact that the EMA does not require complete duplication of the reference product’s clinical trial programme.
Sandoz Biopharmaceutical’s global head, Saaid Mallik, said that this is an important decision and the ramifications of which will go far beyond the UK.
