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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