UK’s NICE issues first biosimilar recommendation

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UK’s NICE issues first biosimilar recommendation

INICIO/Políticas y legislación | Posted 29/10/2010 0 Post your comment

In a report published in May 2010 the UK’s National Institute for Health and Clinical Excellence (NICE) issued its first biosimilar recommendation, saying the biosimilar somatropin offers the same efficacy and safety as originator somatropins.

The guidance recommends somatropin for the treatment of growth failure in children, and includes Sandoz’s Omnitrope (somatropin [rDNA] origin) for injection) as one of seven recommended somatropin products – the first time that NICE has recommended the use of a biosimilar.

This is seen as a landmark decision, by Sandoz, who expect the ramifications of which to go far beyond the UK.

The guidance also recommends that, where more than one product is suitable, the least costly option should be chosen.

The guidance issued by the NICE Appraisal Committee noted that Omnitrope had undertaken head-to-head trials with the reference product as part of its regulatory submission to the EMA and found that there were no differences in terms of safety or efficacy between the products.

In August 2010, Omnitrope also received FDA approval for the new indication, the treatment of idiopathic short stature in children.

Omnitrope was the first product to be approved in the EU as a biosimilar, in 2006.

Related article

EU guidelines for biosimilars

References

NICE. Human growth hormone (somatropin) for the treatment of growth failure in children (review of NICE technology appraisal guidance 42). Final guidance. 26 May 2010.

Sandoz. NICE issues first biosimilar recommendation, saying Omnitrope® offers same efficacy and safety as other somatropins. 26 May 2010.

Sandoz. Sandoz receives FDA approval for another new indication for Omnitrope and launches Patient Assistance Program. 27 August 2010.