Australia approves Sandoz's Omnitrope

The Australian Therapeutic Goods Administration (TGA) confirmed that it approved Sandoz's Omnitrope, a follow-on human growth hormone. The product is indicated 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.

Sandoz, the generics unit of Novartis (NVS; SWX:NOVN), has been blocked in its efforts to obtain biosimilar approval of Omnitrope in both Europe and the U.S. In September, FDA deferred a decision regarding approval of Omnitrope due to scientific and legal issues associated with a regulatory pathway for follow-on proteins (see BioCentury Extra, Thursday Sept. 2, 2004). FDA does not know when it will resolve the outstanding issues. Pfizer (PFE) and Genentech (DNA), which both market hGH products, filed petitions urging FDA to reject the Omnitrope application. NVS's efforts to market Omnitrope in Europe are also stalled pending resolution of legal and regulatory issues (see BioCentury Extra, Monday March 29, 2004). The TGA and Sandoz declined to comment on the basis for the approval. ...