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NICE issues first biosimilar recommendation

NICE has issued guidance saying Sandoz's Omnitrope, for growth failure in children, offers the same efficacy and safety as other somatropins

The UK's National Institute for Health and Clinical Excellence (NICE) has issued final guidance today saying that Sandoz's treatment for growth failure in children, Omnitrope, offers the same efficacy and safety as other somatropins. This is the first time that NICE has recommended the use of a biosimilar.

The latest NICE cost-benefit guidance includes Omnitrope as one of seven recommended somatropin products to treat child growth deficiencies.

NICE says that, when more than one product is suitable, the least costly one should be chosen. It recommends that the doctor and patient choose the somatropin treatment based on therapeutic need and the likelihood of adherence to treatment.  Sandoz is reducing the price of Omnitrope so that from June 1 it will be the cheapest option on the NHS list.

Omnitrope is backed by seven years of quality, safety and efficacy data. The guidance noted that it had undergone head-to-head trials with the reference product as part of its regulatory submission to the European Medicines Agency (EMA) and found that there were no differences in terms of safety or efficacy between the products.

Biosimilars are approved by the EMA on the basis that that they have demonstrated comparable quality, safety and efficacy to the reference product. They are usually priced lower, partly reflecting the fact that the EMA does not require complete duplication of the reference product's clinical trial programme.

"This is an important decision, the ramifications of which go far beyond the UK," said Ameet Mallik, global head at Sandoz Biopharmaceuticals.

"Biosimilars, pioneered by Sandoz, are recognised around the world as having comparable safety, efficacy and quality to existing biopharmaceuticals following loss of patent protection. This latest guidance further reinforces the confidence that leading authorities have in our products."

Sandoz is part of the Novartis group and specialises in generic pharmaceuticals. It has a portfolio of approximately 1,000 compounds and sells in more than 130 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies.

26th May 2010

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