PhRMA reacts to FDA’s biosimilars guidance

15-08-2014

PhRMA reacts to FDA’s biosimilars guidance

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The Pharmaceutical Research and Manufacturers of America (PhRMA) has voiced concerns about the US Food and Drug Administration’s (FDA’s) draft guidance on biosimilars, which it suggests if enacted, could have an impact on the safety of biosimilar products.


PhRMA, FDA, biosimilars, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

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