Sandoz Canada announced this week that it received market authorization for recombinant human-growth hormone marketed as OmnitropeTM in Canada. This approval is the first version of a previously approved recombinant biotechnology drug to be approved by Health Canada under the regulatory term "Subsequent Entry Biologic" (SEB - also known as "biosimilars" in Europe and "follow-on proteins" in the U.S.).
OmnitropeTM, a somatropin (rDNA orign) for injection, is approved for long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone. It is also approved for long-term replacement therapy in adults with growth hormone deficiency due to an underlying hypothalamic or pituitary disease or who were growth deficient during childhood. OmnitropeTM Pen 5 and 10 provides a new convenient delivery system because the liquid is already dissolved in a ready-to-use cartridge that can be loaded into the pen for injection.