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FDA's Decade Of TNF Blocker Experience Eased Path For Simponi Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s first-cycle approval of Centocor’s TNF inhibitor Simponi (golimumab) encapsulates the double-edged position of late entrants into crowded drug classes: while differentiating a new product may pose a commercial challenge, FDA’s experience with early members of the class can smooth the way to approval for late-comers.

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