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Clinical Efficacy And Safety Studies 'Redundant' For Most Biosimilars

‘Residual Uncertainty’ Surrounding Biosimilars Greatly Reduced Since WHO 2009 Guideline Publication

 
• By Chloe Kent

A team of researchers has concluded that in vivo animal studies and large safety and efficacy studies are rarely necessary to license biosimilars.

Insulin vial with syringe
• Source: Alamy

An article published in the journal BioDrugs has concluded that comparative clinical efficacy and safety studies are “redundant” for the evaluation of biosimilars in most cases.

The WHO earlier this year reworked its 2009 guidelines for the development of biosimilars, having begun to consider streamlining the process in 2019

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