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
Colchicine BCS 3
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 3
Telithromycin Data to be generated
Tenofovir Data to be generated
Tenofovir disoproxil BCS 1