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Biosimilars Could Face Data Extrapolation Challenges

By Marie Powers
Staff Writer

Monday, October 8, 2012
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The FDA's decision last week that an approved generic bupropion wasn't comparable to GlaxoSmithKline plc's antidepressant Wellbutrin XL 300 mg (bupropion) raises questions about the hurdles biosimilar developers may face along the new regulatory path.

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