Biosimilar Switching Studies Show No Adverse Efficacy Or Safety Effects, Researchers Say
Sandoz-led review of 90 published studies finds no evidence to support theoretical concern about differences in immunogenicity when switching between reference biologics and their biosimilars; findings could instill more public confidence about biosimilars in US and reduce importance of an interchangeability designation from FDA.
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US FDA’s recommendation against use of foreign-licensed reference products in clinical switching studies would result in procurement challenges and higher costs for biosimilar developers while also limiting where such studies could be conducted, some companies say.