A copycat drug by any other name
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 (sub. req.)


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