Omnitrope(TM) Pen 5 with liquid cartridge, a new form of the first follow-on version of a previously approved recombinant biotechnology drug approved by the Food and Drug Administration. Omnitrope, a somatropin (rDNA origin) for injection recombinant, is approved for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.
The Omnitrope Pen 5 with liquid cartridge approved by the FDA is available in 5 mg strength at a price of USD 33.65/mg, which is approximately 35% 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 of 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 lyophilized 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 recognizes the role that generic drugs and follow-on biologics can play in the health care system.
What HGH therapy can do:
- Reduce excess body fat, especially abdominal fat. (The reduction of abdominal fat is the single most profound effect of HGH replacement in many people.)
- Increase muscle mass (and physical strength if combined with moderate exercise).
- Reduce wrinkling of the skin and some other effects of skin aging.
- Re-grow certain internal organs that have atrophied with age.
- Increase bone density.
- Strengthen the immune system.
- Reverse cognitive decline.
- Stimulate production of the bone marrow cells that produce red blood cells.
- Reduce the probability that you will spend the last years of your life in a nursing home.
What HGH cannot do:
- It cannot eliminate the effects of oxidation damage, although it may alleviate some of it.
- It cannot undo the effects of cardiovascular disease, although it sometimes reduces some of its effects. It can also slow its progression by improving one's cholesterol profile.
- It cannot eliminate the effects of the reduction of other hormones. In fact, a deficiency of certain other hormones will decrease the beneficial effects of HGH.
- It cannot significantly reverse the damage to human proteins caused by glucose, although it may reverse a little of this damage.
- Although it helps skin to look younger, it cannot eliminate all of the damage cause by sunlight and other ultraviolet sources.
- It cannot increase maximum lifespan. For many people with HGH or IGF-1 genetic defects, it can significantly extend life expectancy.
How does HGH get produced naturally:
HGH is produced by the pituitary gland. The ability of the pituitary gland to produce HGH declines very little with aging in most people. The decline with aging occurs one step back from the actual secretion of HGH. There are at least 3 substances which control HGH secretion:
- Growth hormone releasing hormone (GHRH), a substance which declines with age. Increasing levels of GHRH causes the pituitary to increase its output of HGH.
- Growth hormone releasing peptide (GHRP) is another substance that declines with age. Increasing levels of GHRP also causes the pituitary to increase its output of HGH.
- Somatostatin is a hormone that blocks the release of HGH by the pituitary gland. The natural production of somatostatin increases with age, and causes a corresponding decrease in HGH production by the pituitary gland.
- The production of HGH is controlled by GHRH, GHRP, somatostatin, and other substances in the body. The degree to which changes in the levels of each of these substances is responsible for the decline in human growth hormone varies from individual to individual, and is somewhat gender-dependent.