Sandoz wins EU approval for Omnitrope

Novartis' generic drug unit Sandoz has won European Commission approval to market Omnitrope, a human growth hormone that will become the first new biosimilar to hit the market. Sandoz expects to waste no time in introducing the human growth hormone, with marketing to begin once it has negotiated prices with European governments. Omnitrope is a biogeneric of Pfizer's Genotropin. Only yesterday a federal judge ordered the FDA to make a decision on Omnitrope after sitting on Sandoz's application for more than two years. The biotech industry has steadfastly opposed approval of biogenerics, or biosimilars, arguing that biologics are far too complex to permit others to manufacture knockoffs. A number of human growth hormones have been approved in recent years, though, with payers seeing little difference between them.

- read the AFX report for more on Omnitrope

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