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Why Sandoz is Shaking Up the World of Biologicals

This article was originally published in RPM Report

Executive Summary

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.

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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.

Paving the Critical Path for Innovation in the Biotechnology Industry

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