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Sandoz Will Steer Clear Of U.S. Biosimilars Pathway, Use Other Applications

Executive Summary

Drug companies looking to bring biosimilars to the U.S. market will use existing regulatory pathways like 505(b)(2) or an outright Biologics Licensing Application over a new regulatory pathway provided in the health care reform legislation because of provisions in the new pathway that favor brands, Jeff George, the head of Sandoz, predicted

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