Sandoz Pharmaceutical has received marketing authorisation for the Japanese biosimilar, recombinant human growth hormone somatropin.
The drug is used for the treatment of growth hormone deficiency in children, and growth disturbance associated with Turner’s syndrome or chronic renal insufficiency.
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The Japanese Ministry of Health, Labor and Wealth announced the approval on 22 June 2009, based on similar scientific principles to those approved in the EU.
Sandoz CEO Jeff George said that the company was pleased to make inroads into Japan.
“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, in Japan and worldwide,” George said.
The Sandoz product will be marketed in Japan as Somatropin BS SC injection 5mg/10mg. Sandoz somatropin is already marketed as Omnitrope in the EU, the US and Australia.
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