Sandoz Canada received market authorization for Omnitrope in Canada. Omnitrope is the first biosimilar of a previously approved recombinant drug to be approved by Health Canada under Subsequent Entry Biologic (SEB).

Omnitrope, a somatropin (rDNA origin) for injection, is approved for the long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone, and 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.

The Omnitrope Pen 5 mg and 10 mg strengths, with liquid cartridges, have been approved by the Biologics and Genetic Therapies Directorate of Health Canada. With this new delivery system, the liquid is already dissolved in a ready-to-use cartridge and can be loaded into the pen for injection.

“Subsequent Entry Biologics, known as biosimilars in Europe and follow-on proteins in the US, are a key part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits,” said Pierre Frechette, president and chief executive officer of Sandoz Canada. “Due to the rising cost of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring access to medicines.”