Sandoz, a division of Novartis, launched Omnitrope Pen 5 in the US. Omnitrope with liquid cartridge, a new form of the first follow-on version of a previously approved recombinant biotechnology drug, is approved for long-term treatment of paediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.
Omnitrope, a somatropin (rDNA origin) for injection recombinant, approved by the FDA is available in 5 mg strength at a price of USD 33.65/mg, which is approximately 35 per cent less than the published price for Genotropin, the comparator reference product, and other leading recombinant growth hormones. 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.
According to the FDA, Omnitrope is highly similar to Genotropin in its pharmacokinetic/pharmacodynamic, safety and efficacy profiles, which is a very high regulatory standard and the same comparability standard currently applied to brand products when they make manufacturing changes.
"The Omnitrope Pen 5 with liquid cartridge represents Sandoz commitment to meeting the needs of patients through providing more convenient delivery systems," said Bernhard Hampl, chief executive officer, Sandoz Inc., the US subsidiary of Sandoz. "This launch is another milestone in our continuing efforts to provide US healthcare providers and patients with greater access to high-quality biologic medicines at more affordable prices."
An Omnitrope liquid pen system has been available in Europe since spring 2007. A lyophilised powder form of Omnitrope was launched in the US by Sandoz in January 2007, following its approval by the FDA in May 2006 under the 505(b)(2) Pathway of the Hatch-Waxman Act. Shortly prior to that, Omnitrope was also the first biosimilar to be approved in Europe. No other follow-on biologic (referred to as biosimilars in Europe) has received approval and been made available to patients in both regions.
Sandoz strongly supports a balanced position on follow-on biologics, which advocates that the same standards of high quality and science consistently be applied to all medicines, ensures respect for legitimate intellectual property, and recognises the role that generic drugs and follow-on biologics can play in the health care system.