We were excited to have Vladimir Hanes, Medical Director of Oncology/Biosimilars at Amgen, share his expertise on the structure, function, and the science of biosimilarity in designing meaningful biosimilar development programs at last year’s World Biosimilar Congress USA.
You can now download Vladimir’s presentation to find out more about:
- FDA & EU definitions of biosimilars
- Generics and biosimilars
- The biotechnology manufacturing process
- Development steps and residual uncertainty
- Cell-line and process case studies
- How PK results demonstrate bioequivalence
The World Biosimilar Congress USA is where biopharma developing biosimilars gather to discuss how to access the US market. This year’s event will take place May 19-20 at the Hilton San Diego Resort and Spa.