NEW YORK French drug maker Sanofi-Aventis is suing to stop Sandoz’ generic version of its blood thinner from reaching the market, according to published reports.
But the National Law Journal reported Monday that the case could have implications for the future of biosimilars and possibly make getting them to market more difficult. While the drug, Lovenox (enoxaparin), is officially a pharmaceutical drug -- a form of heparin, drawn from the intestines of pigs -- its complexity means that it is ranked alongside biotech drugs by companies like market research firm IMS Health, IMS VP industry relations Doug Long told Drug Store News.
The National Law Journal reported that many are seeing the case as determining how the Food and Drug Administration handles biosimilars, for which an abbreviated regulatory approval pathway was created with the passage of the health-reform bill.
“The law has been passed; the regulations are being written,” Long told Drug Store News. “The question is, is Lovenox an aberration or the start of a trend?”