April 21, 2006
Novartis gets EU OK for first-ever copycat of biotech drug
The European Commission has granted Novartis’ Sandoz unit the first-ever authorization to market a copycat version of a biotech medicine.
Novartis said Tuesday it received approval for Omnitrope, a recombinant human growth hormone. Omnitrope is an equivalent version of Pfizer’s human growth hormone Genotropin and Serono’s Saizen.
Novartis is expected to market the product soon, with Germany and Austria being the first markets in Europe where the drug will be available. Omnitrope is currently on the market in Australia, where it was launched in 2005.