The National Institute for Health and Clinical Excellence has approved the use of Sandoz’ Omnitrope on the National Health Service, marking the first time it has recommended a biosimilar medicine.

The cost regulator has published final guidance clearing the use of Omnitrope, a follow on biologic to Pfizer's Genotropin (somatropin) and the first biosimilar to receive the regulatory green light in Europe, as one of seven somatropin-based products to treat growth failure in children on the NHS.

The seven versions of somatropin approved for the NHS are: Pfizer's Genotropin; Eli Lilly’s Humatrope; Novo Nordisk’s Norditropin SimpleXx; Ipsen’s NutropinAq; Merck Serono’s Saizen; Ferring’s Zomacton; and Omnitrope, as the only follow-on biologic.

Biosimilar products are usually cheaper than their reference drugs, and this could prove to be an important advantage for Omnitrope as NICE has stipulated that, if treatment with more than one product is suitable, the least costly should be used.

“This is an important decision, the ramifications of which go far beyond the UK,” said Ameet Mallik, global head of 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,” he noted.

Richard Stanhope, a consultant paediatric endocrinologist with 10 years of clinical experience with Omnitrope, said he welcomed the decision by NICE to recommend a biosimilar as an option for growth disorders in children. “It will benefit patients by providing an alternative, equally effective treatment option as well as offering much needed cost savings to the NHS,” he explained.

Somatropin, which can add as much as 11cm to a child’s height depending on their condition, is the only active treatment for children who are not growing normally, and so the decision to fund the drug’s use on the NHS will be “welcome news to those who are affected”, said Carole Longson, director of NICE’s Health Technology Evaluation Centre.

Chronic hepatitis C update
Elsewhere, the Institute has also published draft guidance for the treatment of chronic hepatitis C in which it recommends the wider use of Roche’s Pegasys (peginterferon alfa), reflecting changes in the licensed indications for the drug.

A combination of Pegasys and ribavirin is now also recommended for patients who have failed to responded to or have relapsed following initial treatment and for those also infected with HIV, boosting the number of people with hepatitis C who could potentially benefit from treatment with the drug.

In addition, shortened courses of the combination treatment, in line with the licensed indications for these drugs, are also being endorsed as an option, which may be welcome news for patients having difficulty tolerating the side effects associated with the therapy.

“Widening access to these drugs will not increase the NHS drug budget by much but will give clinicians and people living with hepatitis C more treatment options,” commented Gillian Leng, NICE’s Deputy Chief Executive.