FDA Issues Draft Guidance for Biosimilar Products
(medpagetoday.co) (MedPage Today) -- Manufacturers of 'biosimilars,' or generic biologic drugs, should consider using a 'stepwise' approach to demonstrate their product's similarity to something already on the market, the FDA said in draft guidance issued Thursday.
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updated 15793 (Medical - Health & Policy), inserted 15, updated 0, at 2012-05-31 07:11:33
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