Somatropin launch paves way for entry of biosimilars in Japan

Sandoz, the generics division of Swiss drugmaker Novartis, has launched its recombinant human growth hormone somatropin in Japan, the first biosimilar to be approved and launched in the world's second-largest pharmaceutical market.

The move follows the approval of the drug, already sold as Omnitrope in the EU, the US, Australia and elsewhere, by Japan's Ministry of Health, Labour and Welfare (MHLW) in June.

The drug is approved in Japan for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency, the same indications as the reference product, Genotropin.

Sandoz pioneered the field of biosimilars with the approval and launch of Omnitrope and the introduction of Binocrit across Europe. Biosimilars are approved on the basis that they have demonstrated comparable quality, safety and efficacy to the reference product. Sandoz is the only company with three biosimilar medicines marketed in Europe.

"Biopharmaceuticals offer real therapeutic hope to those suffering from the most complex diseases of modern society," said Jeff George, chief executive of Sandoz. "Biosimilars, pioneered by Sandoz, increase access to these essential drugs, lowering treatment costs and saving money for the healthcare system."

The somatropin approval came three months after the Japanese authorities published guidelines that paved the way for a national biosimilar regulatory pathway, based on similar scientific principles to the approval pathway already in place in the EU.

The Sandoz product will be marketed in Japan as Somatropin BS S.C. injection 5mg/10mg.