FDA Urged To Scrap Biosimilar Clinical Testing

September 10, 2018
FDA is facing pressure to eliminate the requirement that biosimilar sponsors conduct confirmatory powered clinical studies. Two top scientists argue that these late-stage trials duplicate the analytical testing required by FDA, add unnecessary cost and violate congressional intent. The agency has approved 12 biosimilars, and all went through what FDA calls a “stepwise approach to demonstrate biosimilarity.” The process begins with analytical testing. From there sponsors use animal data to measure toxicity and then comparative human PK and PD studies...

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