Sandoz wins Canadian approval for Omnitrope growth hormone

Omnitrope is reported to be the first version of a previously approved recombinant biotechnology drug to be approved by Health Canada under the regulatory term ‘subsequent entry biologic’.

Approval of Omnitrope as first subsequent entry biologic increases access to high-quality medicines and offers patients safety and efficacy combined with greater cost effectiveness, the company said.

Omnitrope, a somatropin 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.

According to Sandoz, the Omnitrope Pen 5 and 10, with liquid cartridges, have been approved by the Biologics and Genetic Therapies Directorate of Health Canada in 5mg/1.5ml and 10mg/1.5ml strengths. This new delivery system is more convenient for patients because the liquid is already dissolved in a ready-to-use cartridge and can be loaded into the pen for injection, the company added.

Pierre Frechette, president and CEO of Sandoz Canada, said: “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. Due to the rising cost of healthcare and the growing need for more complex treatments, they will play an increasingly important role in ensuring access to medicines.”