Door opens for cheap copies of biotechnology drugs

The health regulator, which is awaiting confirmation of its decision from the European Commission, agreed that Omnitrope, a growth hormone produced by Sandoz, had shown similar quality and efficacy to that of Genotropin, the original version of the drug, made by Pfizer, reports the Financial Times. The decision by the agency removes a big obstacle in Europe to so-called bio-similar products – generic copies of biopharmaceuticals already on the market – and is a big opportunity for generics manufacturers with technological know-how to make the complicated drugs. The ruling also puts the EU ahead of the US, where the regulator is dithering over approval of generic copies of biotechnology drugs. Full Financial Times report