The guidance issued by the NICE Appraisal Committee noted that Sandoz’s 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 has said 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.
Sandoz has said that Omnitrope was the first product to be approved in the EU as a biosimilar, in 2006. It now has seven years’ of comparable efficacy and safety data including clinical trial phase data.
Ameet Mallik, global head of Sandoz Biopharmaceuticals, said: “This is an important decision, the ramifications of which go far beyond the UK. Biosimilars, pioneered by Sandoz, are recognized around the world as having comparable safety, efficacy and quality to existing biopharmaceuticals following loss of patent protection.”