Sandoz receives approval for first Japanese biosimilar
Sandoz, the generics division of Novartis, has become the first company to receive marketing authorisation for the first-ever biosimilar in Japan.
Sandoz, the generics division of Novartis, has become the first company to receive marketing authorisation for the first-ever biosimilar in Japan.
Japan's Ministry of Health, Labour and Wealth (MHLW) has approved the recombinant human growth hormone somatropin for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency.
The approval comes 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: "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."
The Sandoz product will be marketed in Japan as Somatropin BS S.C. injection 5mg/10mg [Sandoz]. It will be for the same range of indications as Pfizer's reference product, Genotropin, as approved in Japan.
Sandoz said biosimilars are an integral part of its strategy after it pioneered this type of product with the approval and subsequent launch of Omnitrope in the US and Europe. Omnitrope was the first medicine to be approved in the EU as a biosimilar, the European regulatory term for such products.
