Biosimilar Product Development Fee Should Be Temporary, Trade Groups Say

By Derrick Gingery / Email the Author / “The Pink Sheet” Jun. 20, 2011, Vol. 73, No. 25
Regulatory Update / Word Count: 1506 / Article # 00110620012

Executive Summary

Brand and generic drug trade associations disagree with FDA’s proposal to have biosimilar sponsors pay a product development fee before even submitting a marketing application.

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Biosimilar Product Development Fee Should Be Temporary, Trade Groups Say

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