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www.fdanews.com/articles/138023-biosimilars-makers-are-facing-tough-approval-path-decisions

Biosimilars Makers Are Facing Tough Approval-Path Decisions

June 30, 2011
The U.S. law creating the regulatory framework for follow-on biologics is a “shoddy construction,” leaving companies with a tough decision on how to seek regulatory approval, just as the biosimilars industry is taking shape, an analyst says.
Washington Drug Letter