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Regeneron Pharmaceuticals, Inc. Message Board

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  • lordjeff37 lordjeff37 Aug 4, 2011 12:38 PM Flag

    Congressional oversight of pricing will KILL REGN

    "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use."[1]

    how does it not fit this description? National Institute of Health says Avastin is equivalent to trap eye, but at 1/50th the cost

    regn = next dndn

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    • Whether you agree with it or not, the "intended use" definition pulls directly from the approved Avastin indication. In addition, the only route of administration approved in Avastin's label is via IV, and not ITV injection as Lucentis/Eylea is/will be. Since treatment of AMD is NOT an approved intended use for avastin, it can't be defined as a generic to Lucentis/Eylea. The NIH is not the FDA and thus can't define the approved indication label, regardless of whether it considers it equivalent or not.

      You're taking out your frustration on the wrong entity...

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