Japan Launches First Biosimilar Somatropin

4 October 2009 (Last Updated October 4th, 2009 18:30)

Somatropin growth hormone deficiency treatment, manufactured by Sandoz, has become the first biosimilar to be launched in Japan. The launch, which follows precedent-setting approval in June this year, is expected to pave the way for the entry of biosimilars as affordable, high-quality v

Somatropin growth hormone deficiency treatment, manufactured by Sandoz, has become the first biosimilar to be launched in Japan.

The launch, which follows precedent-setting approval in June this year, is expected to pave the way for the entry of biosimilars as affordable, high-quality versions of patent-lapsed biopharmaceuticals in Japan

Somatropin, which is approved in Japan for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency, is the biosimilar equivalent of Pfizer’s Genotropin.

Sandoz Japan country head Junichi Nakamichi said that the company looks forward to helping ensure the country benefits fully from the potential of these remarkable new medicines

“Japan can learn some valuable lessons from the market experience and data provided by the European example,” Nakamichi said.

Biosimilars are approved on the basis that they have demonstrated comparable quality, safety and efficacy to the reference product.

Sandoz is a pioneer in this field following the launch of Omnitrope, the first such product and the first medicine to be approved in the EU as a biosimilar.