The European Commission [1] has given Sandoz, the generic division of Novartis, approval for the sale of a generic version of a human growth hormone [2], making it the first generic of a biotechnology drug [3] authorized for sale in Europe.
The approved drug, Omnitrope®, is based on Pfizer’s Genotropin, a treatment for abnormal growth and growth hormone deficiency in children and adults. The active substance of Omnitrope is somatropin, a growth hormone produced by recombinant DNA technology. Somatropin is a hormone of importance for growth and for the metabolism of lipids, carbohydrates and proteins.
Earlier, the European Medicines Agency [4] recommended approval [5] of Omnitrope [6]. In addition to the European Union, Australia approved Omnitrope sales last year.
Sandoz has asked the FDA to approve Omnitrope in the U.S., “acknowledging the sound science that supports this product.” So far, the FDA has not been keen on biogenerics and has not approved Sandoz’ 1994 application to make and sell Omnitrope in the U.S. even though regulators in Australia and the European Medicines Agency found Omnitrope showed comparable quality, safety and efficacy to Pfizer’s Genotropin.
Sandoz sued the FDA last year and a judge in the U.S. District Court for the District of Columbia ordered the FDA to make a decision [7] after FDA Acting Commissioner Andrew von Eschenbach disclosed the agency wouldn’t release long-awaited guidelines on how to best test generic versions of insulin and human growth hormones, the compounds generic companies most want to copy.