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Expert Analysis

The Challenges Of FDA's Nascent Biosimilars Regime

Law360 (November 17, 2010, 5:08 PM EST) -- As we enter the brave new world of biosimilars, the first obstacle for the U.S. Food and Drug Administration and the industry will be developing approval standards. Although biosimilars offer a significant opportunity to potentially reduce the cost of biologics for patients, the significant safety and efficacy issues that are involved will require a comprehensive evaluation by the FDA. Those biosimilar companies who go to the FDA early and often, and who can effectively advocate for the desired approval standards for particular products, will be the ones who are initially successful in this nascent industry....

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