FDA has tweaked its biosimilars guidances to give sponsors more information about how to bridge data, extrapolate from one condition, choose a study population, and conduct immunogenicity testing.
At the end of April, the agency issued three final guidances with modifications to draft documents published in 2012 Also see "FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics" - Pink Sheet, 9 February, 2012.
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