Novartis’ generics division Sandoz has become the first company to receive marketing authorisation for the first-ever biosimilar to get the green light in Japan.
Japan’s Ministry of Health, Labor and Wealth 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 MHLW has backed the drug because it offers patients comparable quality, safety and efficacy to the reference product, Pfizer’s Genotropin, and the approval covers the same range of indications covered by the latter.
The green light comes just three months after the Japanese authorities published guidelines that paved the way for a national biosimilar regulatory pathway, based on similar scientific principles already in place in the European Union, Novartis noted. Sandoz chief executive Jeff George said that the company, “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 copycat version of Genotropin is already available in the USA and Europe and is marketed as Omnitrope. Sandoz added that biosimilars are “an integral part” of its strategy, “ due to the rising costs of health care and the growing need for more complex treatments”.
The company, which is based in Holzkirchen, Germany, said it is building a “strong global biosimilar pipeline, with numerous projects at all stages of development”. It has three biogenerics marketed in Europe – Omnitrope, the neutropenia treatment filgrastim (a generic version of Amgen’s Neupogen) and a biosimilar of Johnson & Johnson’s anaemia drug Epogen (epoetin alfa).
