Legislative of Omnitrope

The Sandoz Incorporated, a generics arms of Novartis application to market Omnitrope (a Somatropin rDNA origin) has been approved by the US Food and Drug Administration. The product is a follow-on version of a recombinant HGH or Human Growth Hormone product that has been previously approved.  The decision of approval by the FDA on the product Omnitrope has been backed by the European regulatory authorities in April 2006. The corporation had filed a lawsuit that seeks a ruling on their new drug application against the FDA in September 2005 and filed in July 2003.

Upon Approval

In approving Omnitrope, the US Food and Drug Administration informs the public that the drug is not a generic biologic primarily because it has not been rated as an equivalent to any therapeutically approved HGH or human growth products. The FDA emphasized the Omnitrope as a follow-on protein product.  Upon approval, the Omnitrope in a 505 (b)(2) application does not create a way for approving follow-on products for any biological products under and licensed on Section 351 of the public health service act – thus, it doesn’t mean that less or complex that is well-understood proteins are all approved as human use safe drugs under the FDC Act or the Food, Drug, and Cosmetic act as follow-on products according to FDA.

Approval Limitation

As the FDA said that the majority of protein products that are licensed under the public health service act as biological products and not drugs under the FDC Act. Any pathway for the licensure or approval of follow-on protein products under the PHS Act would require new legislation. In addition, the FDA also pinpoint that upon the Omnitrope approval, it doesn’t involve any legal or regulatory questions that are raised with the follow-on products licensed under the public health service act. These problems or issue may involve any protein products that have unknown or multiple active ingredients, protein products that are glycosylated, and protein products that have any unknown action mechanism.

The Omnitrope made by Sandoz incorporated is not the first approve drug from the US Food and Drug Administration under section 505 of the Food, Drug, and Cosmetic Act. Other follow-on protein product includes Hylenex (Hyaluronidase recombinant human), GlucaGen (glucagon recombinant for injection), Amphadase and Hydase (hyaluronidase), and Fortical nasal spray (calcitonin-salmon recombinant).

Sandoz Company stated that while rigorous scientific criteria should be applied consistently to the process of approval for all follow-on biotechnology medicines and the unnecessary or unethical duplication of animal studies as well as human clinical trials should necessary to be avoided in order to reduce the wasted resources that could be invested in continuous improvement and innovation. They added that these types of medicines should only be produced and approved once the patents are expired without any reference to the confidential commercial information of innovators and trade secrets.

The Omnitrope has been clearly seen to have a positive effect for treating growth disorders and hormonal imbalances in both children and adults throughout the USA. It is also the equivalent to the Genotropin product made by Pfizer, the leading HGH product in the USA and Europe. According to IMS data, the market for people who buy Omnitrope and other HGH products in the US was around $600 million in 2005.  Omnitrope has been introduced to the European Union on April 19 and launched in Germany in 2006 and in Australia in November.

The Sandoz spokesman stated that the company is developing 5 other follow-on biologic or biosimilar at various stages of development. He would not divulge their identity for commercial reasons and other first-generation biologics that lost their patent protection includes insulin, erythropoietin, colony stimulating factors, and interferon Alfa. The annual sales of biologics are estimated at around $20 Billion are vulnerable to generic competition as they are out of the patent protection.

Approved use of Omnitrope

The synthetic growth hormone is approved for treating children with human growth hormone deficiency or hormonal imbalance characterized by short-stature and unusual height. The Omnitrope promotes growth and supplements the levels of growth hormone among children especially those who are born small for gestational age with a smaller height than contemporaries by ages 2-4. Omnitrope is also beneficial for young people with Turner Syndrome that is characterized by unusual height for unknown reasons.

The brand is also used for treating adults with growth hormone deficiency conditions and it is approved for childhood or in adulthood. The hormonal imbalance can be caused by several factors including surgery, trauma, hypothalamic, pituitary disease, or radiation therapy.

Before deciding to use Omnitrope, you must first inform your doctor about all your past and present medical conditions such as allergies, diabetes, cancer, scoliosis, high blood pressure, underactive thyroid, brain tumor, kidney complications, liver disease, breathing problems, or pancreas disorder. Administer the drug only with a health professional care and advice to avoid any complications that may happen due to the Omnitrope possible side effects.