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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 …
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