Biosimilars
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 provide you with a global overview of biosimilars and how they differ from the original biological product. The programme will discuss the unique considerations of biosimilars as compared with small molecule generics.
Our expert trainer will cover the regulatory pathways and challenges for both the EU and US for biosimilars, and explore the key dossier requirements for biotech products compared to pharma products. Strategies for development of biosimilar products will also be discussed and 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
Upcoming start dates
Request information - obligation free
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Reviews by course attendees
Average rating 4.8
I gained much more understanding than what I had intended to. The trainer also involved everybody in the course and did not make it boring. The topics of non-clinical, clinical,...
Globally good presentation, speaker tried to make people participate which is difficult by webinar.
Overall I found this course really helpful and informative. One of the most enjoyable and informative seminars I have ever attended. Thank you for organizing and a very special...