Sandoz Canada has received market authorization for Omnitrope in Canada. Omnitrope 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).
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 and 10, with liquid cartridges, have been approved by the Biologics and Genetic Therapies Directorate of Health Canada in 5 mg/1.5 mL and 10 mg/1.5 mL 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.
"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 Fréchette, president and CEO 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."
Sandoz is the pioneer in this new field, with three biosimilar medicines already approved and marketed in Europe: Omnitrope (somatropin), Binocrit / Epoetin alfa Hexal (erythropoetin) and Filgrastim Hexal (GCSF) - also approved as Zarzio. Omnitrope was the first ever medicine to be approved under the regulatory term 'biosimilar' in Europe and is also approved and marketed as a 'follow on protein' in the US. Sandoz continues to develop a comprehensive biopharmaceuticals pipeline, with numerous projects at various stages of development.
This pioneer position is based on decades of experience in biotechnology manufacturing for both internal and external customers as well as significant cross-divisional synergies within the Novartis Group including a joint global Technical Development and production network. Sandoz strongly supports a balanced position on SEBs, which advocates that the same standards of high quality and science consistently be applied to all medicines, and recognizes the role that generic drugs and Subsequent Entry Biologics can play in the healthcare system.
With more than 209 molecules, Sandoz offers one of the broadest portfolios of products in Canada. Sandoz continues to showcase its leadership by adding to its portfolio each year through product development and innovation in oral, injectable and difficult-to-make products, such as modified release and Subsequent Entry Biologics.
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products.