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Home » Biosimilars Makers Are Facing Tough Approval-Path Decisions
Biosimilars Makers Are Facing Tough Approval-Path Decisions
June 24, 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.