Background

BCS-based Biowaivers

Our attention to BCS-based biowaivers  is an imprint of the fact that they represent intelligent, ethical, time and cost-saving concept for product launch. 

We know how to put the pieces together: 
  • use maximum amount of existing evidence of permeability/absorption/bioavailability
  • advise on what additional data needs to be generated for your substance to be classified BCS 1/3
  • write  convincing and strong justification
Reflecting our experience we highly recommend prospective development approach to avoid issues with excipients, unsimilar dissolution profiles, costly and time-consuming analytical testing.  
Drugs where BCS-based biowaiver is clearly supported by EMA (Product-Specific Guideline)
Agomelatin BCS 1
Aliskiren BCS 3
Apixaban Data to be generated
Emtricitabine BCS 1
Entecavir Data to be generated
Imatinib (possible BCS 1)
Lenalinomide (possible BCS 1)
Memantine BCS 1
Miglustat Data to be generated
Oseltamivir (possible BCS 3)
Paracetamol BCS 1
Sitagliptin BCS 1
Sunitinib BCS 1
Telithromycin Data to be generated
Tenofovir Data to be generated
Tenofovir disoproxil BCS 1