PharmiWeb.com - Global Pharma News & Resources
30-Sep-2019 - 01-Oct-2019

Biosimilars

  • Location:
    • The Rembrandt Hotel
    • Thurloe Place
    • London
    • Greater London
    • SW7 2RS
    • United Kingdom
  • View on a map

With some of the world’s best-known biologics continuing to face patent expiration in the coming years, the biosimilar market is set for continued growth.

This seminar will cover the regulatory pathways for both the EU and US and how to develop effective strategies for developing biosmilar products. You will be introduced to key biological requirements and the concept of totality for biological review.

Benefits of attending:

  • Discuss global considerations and definitions of biotech/biosimilar products
  • Gain an invaluable overview of the regulatory pathways for biosimilars in the EU and US
  • Understand the key Module 3 dossier requirements for biotech products versus pharmaceutical products
  • Learn how to develop effective strategies for development of biosimilar products