Module 9 2021

22/03/2021

BIOSIMILAR REGS WERE BORN IN EU

Quality guideline Revision (2012)

Directive 2003/63/EC

Reference: Updated from Alberto Ganan Jimenez & Brigitte Brake (May, 2011): Biosimilars in the European Union -regulatory perspectives, Kaula Lumpur, Malaysia

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EVOLVING VIEWS

2006

— Quotes from Nature Reviews Drug Discovery 5, 445 (June 2006) What constitutes a biosimilar monoclonal antibody is going to open up a completely new discussion In my view you always need to consider them as a unique protein It remains to be seen whether the development of a biosimilar mAb is possible and feasible

2008

— Schneider and Kalinke, Nature Biotech 09/2008

2012

As of this time, there is no MAA for a biosimilar mAb, but the stage is set

— Schneider et. al, Nature Biotech 12/2012

2013 First biosimilar mAb, approved in EU!

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