TOKYO The generics arm of Swiss drug maker Novartis has launched Japan’s first biosimilar.
Sandoz announced Monday the introduction in Japan of somatropin, a recombinant human growth hormone used to treat growth disturbance in children associated with chronic renal insufficiency, also known as Turner’s syndrome. Somatropin is the first biosimilar to receive approval in Japan and is a follow-on version of Pfizer’s Genotropin.
Sandoz has already launched it under the brand name Omnitrope in Australia, the European Union and the United States. Unlike the European Union and Australia, United States lacks an abbreviated approval pathway for biosimilars, but a federal judge ordered the Food and Drug Administration to act on Sandoz’s approval application for Omnitrope in 2006, leading the agency to approve it as a drug rather than as a biologic.
“Biopharmaceuticals offer real therapeutic hope to those suffering from the most complex diseases in modern society,” Sandoz CEO Jeff George said in a statement. “Biosimilars, pioneered by Sandoz, increase access to these essential drugs, lowering treatment costs and saving money for the healthcare system.”