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Abbott files Humira for Crohn’s

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Abbott has submitted an sBLA for Humira (adalimumab) for treatment of moderate-to-severe Crohn's disease, the company announced Sept. 7. Abbott is highlighting its anti-tumor necrosis factor monoclonal antibody's dosing advantage over Johnson & Johnson's anti-TNF MAb Remicade (infliximab); Humira is injected subcutaneously every other week for Crohn's, while Remicade requires infusion. UCB's Cimzia (certolizumab pegol), a fragment of an anti-TNF MAb, is also dosed subcutaneously and is likely to be approved for Crohn's before Humira: UCB submitted a BLA Feb. 28, 2006, and is predicting launch in the first half of 2007...
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