Sandoz, a division of the Novartis, received US FDA approval for its recombinant human growth hormone Omnitrope as the first follow-on version of a previously approved recombinant biotechnology drug in the US. Omnitrope was approved in the US using the so-called 505(b)(2) pathway of the Hatch-Waxman Act, becoming the first recombinant copy of a biotech drug to be approved by this manner.
Omnitrope is indicated for treatment of growth disorders in children and adults. "The FDA's approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for health care providers and patients worldwide," said Dr. Andreas Rummelt, CEO of Sandoz. "The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the US."
The FDA's decision follows the approval of Omnitrope on April 19 by the European Commission. Omnitrope is now on the market in Germany, with launches planned for additional countries in Europe later this year. Omnitrope is also available in Australia, where it was launched in November 2005, a Novartis press release stated.
Biotechnology medicines are produced in living organisms altered by recombinant technology, and being proteins, are larger than smaller pharmaceutical molecules produced by organic synthesis. However, using advanced product development, analytical methodologies and manufacturing processes, companies like Sandoz can manufacture high quality medicines and bring them to market with savings for patients and payers. As more recombinant biotechnology medicines lose protection in the coming years, these products are expected to play a key role in the growth strategy of Sandoz.