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news.For treatment of growth hormone deficiency in children, and growth disturbance associated with Turner's syndrome or chronic renal insufficiency
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Sandoz has received marketing authorization for the Japanese biosimilar, recombinant human growth hormone somatropin.
The Ministry of Health, Labor and Wealth announced the approval on June 22, 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 SC 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.
Sandoz somatropin is already marketed as Omnitrope in EU, the US and Australia.
Jeff George, CEO of Sandoz, said: We are pleased that Sandoz is paving the way in Japan as well. 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.