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NICE Issues First Biosimilar Recommendation

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The UK’s National Institute for Health and Clinical Excellence (NICE) has published final guidance on the relative cost and effectiveness of somatropin products to treat child growth deficiencies.

The NICE guidance recommends the use of Sandoz’s Omnitrope® (liquid somatropin for injection) as one of seven recommended somatropin products - the first time that NICE has recommended the use of a biosimilar.

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 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 they have demonstrated comparable quality, safety and efficacy to their reference product.

They are generally priced lower than the reference product, partly reflecting the fact that EMA does not require complete duplication of the reference product’s clinical trial program.

NICE says that, when more than one product is suitable, the least costly option should be chosen.

NICE recommended that a discussion should be held between a clinician and patient to choose the somatropin treatment received, based on therapeutic need and the likelihood of adherence to treatment.

“This is an important decision, the ramifications of which go far beyond the UK,” said Ameet Mallik, Global Head Sandoz Biopharmaceuticals.

Mallik continued, “Biosimilars, pioneered by Sandoz, are recognized 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.”

Dr Richard Stanhope, Consultant Pediatric Endocrinologist, said: “I have 10 years of clinical experience using Omnitrope® with my pediatric patients and I believe it is both effective and well tolerated. I welcome the decision by NICE to recommend the option of a biosimilar; it will benefit patients by providing an alternative, equally effective treatment option as well as offering much needed cost savings to the NHS.”

Omnitrope® was the first product to be approved in the EU as a biosimilar, in 2006. It now has seven years’ worth of comparable efficacy and safety data including clinical trial phase data.