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 |