Healthy subjects vs. patients [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2011-11-28 13:56 (4087 d 13:52 ago) – Posting: # 7741
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Dear VM!

❝ […] kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ?


In the EU biosimilars are solely registered centrally at EMA. This process includes submission of protocols and generally scientific advisory meetings… You are aware that you need to perform phase III studies in the patient population to demonstrate safety/efficacy? When it comes to BE, healthy volunteers should be OK – providing safety/efficacy are not an issue. If possible include PD endpoints in the PK studies. See also the recent concept paper.

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