Singapore, Jun 26, 2009: Sandoz, the generic division of swiss drug maker Novartis, has received marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin.

The Ministry of Health, Labor and Wealth (MHLW), Japan announced the approval, barely 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.

 

Commenting on the development, Sandoz CEO Mr Jeff George said, “Together with our parent company Novartis, we are fully committed to broadening access to innovative and affordable biopharmaceuticals over-the-years and decades to come, both in Japan and worldwide.”

 

The Sandoz product will be marketed in Japan as Somatropin BS S.C. injection 5mg/10mg. It is approved for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency. This is the same range of indications covered by the reference product, Genotropin, as approved in Japan. It is approved on the basis that it offers patients comparable quality, safety and efficacy to the reference product, says the company.

Sandoz Somatropin already marketed as Omnitrope in EU, US and Australia.