Sandoz has been granted approval by the FDA for its recombinant human growth hormone Omnitrope as the first follow-on version of a previously approved recombinant biotechnology drug. Omnitrope is indicated for treatment of growth disorders in children and adults. It was approved in the U.S. using the 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 considered a generic version of Pfizer’s human growth hormone Genotropin and Serono’s Saizen.

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.

“The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the U.S.,” said Andreas Rummelt, chief executive of Sandoz. Sandoz believes that rigorous scientific criteria should be consistently applied to the approval process for all follow-on biotechnology medicines. However, the unnecessary or unethical duplication of animal studies and human clinical trials should be avoided so that resources are not wasted that could otherwise be invested in innovation and continuous improvement.

However, according to the FDA, Omnitrope is not precedent setting and is technically not a generic biologic. “The approval of Omnitrope in a 505(b)(2) application does not establish a pathway for approval of follow-on products for biological products licensed under section 351 of the Public Heath Service Act, nor does it mean that more complex and/or less well understood proteins approved as drugs under the Food, Drug, and Cosmetic Act could be approved as follow-on products,” the FDA said. The FDA also claims Omnitrope is not rated as therapeutically equivalent to (and therefore substitutable for) any of the other approved human growth hormone products. Omnitrope is more appropriately characterized as a “follow-on protein product,” according to the FDA.

Sandoz recently won a lawsuit case in April over the FDA’s failure to act on the application.