Why Sandoz is Shaking Up the World of Biologicals
This article was originally published in RPM Report
Novartis subsidiary Sandoz is leading the charge for follow-on biologics. The company makes its case for biogenerics.
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The debate over an abbreviated biologics pathway took a big step forward with the Food & Drug Administration's approval of Sandoz' recombinant human growth hormone Omnitrope. The approval itself is precedent setting, but the bigger ramifications are political: the action steps up the pressure on Congress to address the issue head-on.
Generic biologics was not a priority for Andrew von Eschenbach when he accepted the job as acting commissioner of FDA. But two events -- a federal court ruling requiring a decision on Sandoz' Omnitrope NDA and the European Union approval of the follow-on biologic -- mean FDA may be pressed to take action on a regulatory pathway. The Omnitrope ruling makes it more important than ever that FDA have a fully confirmed leader in place, but it will also make it harder to get one.
Sandoz CEO Andres Rummelt and senior executives explain why the time is ripe for biogenerics in the US.