While Novartis was playing up the FDA's approval of Omnitrope, a follow-on to Pfizer's Genotropin, as a historic first for a biosimilar product, analysts were carefully noting some significant exceptions outlined in the actual FDA decision. The FDA stated that its decision "does not establish a pathway" for other biosimilar approvals. And lawmakers, the agency said, have to change the law before they can approve copycat biotech drugs. Novartis, meanwhile, is planning to sell Omnitrope at a 25 percent discount to Genotropin.
- read the Wall Street Journal report [1] (sub. req.)
Links:
[1] http://online.wsj.com/article/SB114904669181067236.html?mod=health_hs_pharmaceuticals_biotech