Omnitrope launched in Australia

Sandoz launched its Omnitrope somatropin in Australia. The generic drugs subsidiary of Novartis (NVS; SWX:NOVN) said the recombinant human growth hormone (hGH) "is the first product to be developed as a biosimilar and to be approved in Australia." Sandoz said the development program for Omnitrope includes preclinical studies, clinical trials comparing Omnitrope to an originator somatropin and long-term safety and efficacy data. Sandoz has stated that it compared Omnitrope to Genotropin somatropin from Pfizer (PFE) in preclinical and clinical trials.

Omnitrope was approved in Australia in October 2004 for the long-term treatment of children above three years of age with growth disturbances due to insufficient secretion of pituitary growth hormone, growth disturbance associated with Turner's syndrome, and growth disturbance associated with chronic renal insufficiency. ...