This marks first biosimilar to enter the Japanese market.
The Novartis generics business, Sandoz, launched its recombinant human growth hormone somatropin, Somatropin BS S.C., in Japan. The company says the drug is the first ever biosimilar to be approved and launched in that country, which represents the world’s second largest pharma market.
Japan’s regulatory authorities approved the drug in June for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner’s syndrome or chronic renal insufficiency. These indications are the same as for Pfizer’s Genotropin(R), which represents the reference product for Sandoz’ somatropin. Genotropin itself was only approved in Japan during December 2008 for the treatment of short stature/growth problems.
Sandoz’ somatropin biosimilar was first given the go-ahed in Europe and the U.S. in 2006, where it is marketed as Omnitrope®. It represented the first biosimilar product to be approved in both these markets. Omnitrope was also sanctioned in Canada earlied this year. Sandoz now has three biosimilars in Europe: Omnitrope, Binocrit (epoetin alfa; reference products: Amgen’s Epogen and Ortho Biotech’s Procrit, both indicated for Anemia), and Zarzio (filgrastim; reference product: Amgen’s Neupogen for the treatment of neutropenia in certain cancer patients).
In August FDA green-lighted Sandoz’ generic copy of Astellas’ transplant rejection therapy, Prograf (tacrolimus). At the time Astellas said that it would file a complaint challenging the agency’s decision to apply only standard bioequivalence testing for the approval of this drug and other generics of tacrolimus. The FDA previously rejected the firm’s citizen petition asking for such studies.