Part II: Comparing Global Biosimilar Regulation, the EMA, FDA and Their Approval Processes
There are fundamental differences in both the regulatory processes and the market dynamics of the U.S. and the EU that account for much of the discrepancy in the uptake of biosimilars.
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.
This session will dissect the BPCIA, compare it with the European approach, and consider near and medium scenarios for biosimilars in the United States.
Topics of discussion will include:
- Exploring the basics of the BPCIA
- Comparing the European and American approaches
- Considering near and medium scenarios for biosimilars in the United States