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www.fdanews.com/articles/87342-sandoz-approval-could-open-the-floodgates-for-biosimilars-in-us

SANDOZ APPROVAL COULD OPEN THE FLOODGATES FOR BIOSIMILARS IN US

June 6, 2006

German biopharma firm Sandoz has won a landmark first-of its-kind biosimilar drug approval in the US after a long battle with the US Food and Drug Administration (FDA). The decision could open the floodgates for generics manufacturers in this lucrative market.

Outsourcing Pharma (http://www.outsourcing-pharma.com/news/ng.asp?n=68163-sandoz-fda-biosimilar-omnitrope-follow-on-protein)