Follow-on Biologics (EPO)

By Mannheim, Germany 
Feb 2007  
http://www.biogenerix.com/publications/What%20are%20the%20real%20opportunities.ppt
 

ØNo generic approach, i.e. proof of bioequivalence in an abbreviated process is not accepted by EMEA/FDA

ØThe European “comparability guideline” indicates that a complete new filing and clinical trials on a case by case basis are required

ØNo clear regulatory framework

ØBiopharmaceuticals are defined by their production process
à any change can impact safety and efficacy and therefore demands new approval

ØVery difficult patent situation

ØDevelopment time at least twice as long

ØDevelopment costs 8-100 times higher!