The first biosimilar approval follows new Japanese guidelines for regulatory process.

The Japanese regulatory authorities approved Sandoz’ biosimilar recombinant human growth hormone somatropin. The approval is the first ever for a biosimilar in Japan, Sandoz remarks. It follows just three months after the Japanese authorities published guidelines for a national regulatory route for biosimilar products based on the EU’s existing process.

The product will be marketed in Japan as Somatropin. It is indicated for the treatment of growth hormone deficiency in children and growth disruption associated with Turner’s syndrome or chronic renal insufficiency. These are the same indications covered by the reference product, Pfizer’s Genotropin®, which made worldwide sales of $898 million in 2008 (up 6% from 2007). The Sandoz biosimilar was previously approved in both Europe and the U.S. in 2006, where it is marketed as Omnitrope, and was the first biosimilar sanctioned in Europe.

The Japanese growth hormone biosimilar approval follows the February sanction in Europe for Sandoz’ neutropenia biosimilar, filgrastim. It is approved to stimulate production of white blood cells in chemotherapy patients, the same range of indications as its reference product, Amgen’s Neupogen®. Amgen’s  drug made worldwide sales of $1.3 billion in 2008.   

The company’s Epoetin alfa biosimilar, Binocrit®/Epoietin alfa Hexal®, was approved in the EU in 2007 as a direct competitor to Ortho Biotech’s Procrit®/Eprex®, worldwide sales of which declined 14.7% in 2008 to $2.5 billion.

Part of Novartis, Sandoz reports that it is pioneering the emerging biosimilars market. The company claims that by 2010, some 50% of newly approved medicines will be biopharmaceuticals, as an increasing number of major biotechnology-based medicines come off patent and face generic competition.

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