EMA seeks to ease the regulatory burden on biosimilar developers, following push by FDA
The European Medicines Agency earlier this week proposed reducing the regulatory requirements for biosimilar developers due to what it calls “the advances in the analytical sciences and the extensive regulatory experience gained.”
Moving forward, the EMA says it’s reevaluating whether all biosimilar applications will need to include in vivo non-clinical data, as well as other clinical efficacy and safety data.
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