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Sandoz receives approval for first-ever Japanese biosimilar

Sandoz receives approval for first-ever Japanese biosimilar, recombinant human growth hormone somatropin, further reinforcing global pioneer position in field

26 Jun 2009 - Sandoz has received marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin. The Ministry of Health, Labor and Wealth (MHLW) announced the approval on June 22, 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 European Union.
 
Sandoz CEO Jeff George said: "We are pleased that Sandoz, the pioneer in biosimilars and a company with a global reputation for offering high quality medicines at affordable prices, 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."
 
The Sandoz product will be marketed in Japan 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.