Novartis today said Sandoz, a division of the Novartis group, has received marketing authorisation for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin.
The Japanese ministry of health, labour and wealth (MHLW) announced the approval on June 22, barely 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.
The decision will strengthen Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.
Sandoz is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents, with a portfolio of approximately 1000 compounds, sold globally.
Its key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies.
"We are pleased that 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," said Sandoz CEO Jeff George.