FDA OK's the first biosimilar

The FDA has approved Novartis' Omnitrope, a copycat human growth hormone that is patterned on Pfizer's Genotropin. This is the first biosimilar, or biogeneric, product to gain FDA approval, which follows a judge's ruling last month forcing the agency to make a decision on the therapy. Novartis' generic drug subsidiary Sandoz had taken the FDA to court after the agency had left its application in limbo.

"The FDA's approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for healthcare providers and patients worldwide," said Andreas Rummelt, Sandoz chief executive. The decision may signify a landmark event for the FDA, but no one is expecting the agency to suddenly start approving a long list of biotech generics. Human growth hormones are among the oldest and best understood biotech therapies on the market. Biotech companies have long insisted that the bulk of their drugs are too complex to allow generics to take their place. Companies like Sandoz, though, are promising that they can do just that.

- here's the AFX report [1] on the approval