Novartis unit receives first approval in Japan for a biosimilar drug

The Ministry of Health, Labor and Welfare approved somatropin, a recombinant human growth hormone from Novartis' Sandoz unit, marking the first approval in Japan for a biosimilar, the company announced on Thursday.

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

The drugmaker's biosimilar somatropin product is already marketed in Europe, the US and Australia as Omnitrope.

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