Regulatory Affairs in Biosimilars EU vs US 2014

By the end of this decade, a significant number of blockbuster drugs will go off patent, allowing a large number of biosimilar products to enter the market.

- Learn about the latest global regulatory challenges and developments in biosimilar pharmaceutical products
- Analyze current regulatory requirements for biosimilars approval in Europe and USA and the future path of this legislation
- Review the variations between EU and US law and regulations and learn about the process for gaining scientific advice from the FDA and EMA
- Discuss what are the key differences between comparability and biosimilarity from a regulatory perspective


Exclusive Speaker Panel
Speaker Benita von Glahn
Liz Fuller
Cecil Nick
Sharon Longhurst, PhD
Catherine Akers