Biosimilars
Prepare for the biosimilar market growth as some of the world’s best-known biologics face patent expiration in the coming years.
In today's pharmaceutical landscape, the rise of biosimilars presents a pivotal shift in therapeutic options, offering more affordable alternatives to biologics whose patents are expiring. With major biologics facing patent expiration in the near future, the biosimilars market is poised for substantial growth, driving increased interest and investment in this sector.
This seminar delves into the critical distinctions between biosimilars and their reference biologics, addressing the complex regulatory pathways and challenges in both the EU and US markets.
Participants will gain insights into essential dossier requirements specific to biotech products compared to pharma products, alongside strategies for successful biosimilar development. Moreover, the course emphasises key biological considerations and the concept of totality in biological reviews, discussing unique aspects of biosimilars compared to small molecule generics.
This course will equip attendees with comprehensive knowledge essential for navigating the evolving biosimilar landscape.
Upcoming start dates
Suitability - Who should attend?
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
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Reviews by course attendees
Average rating 4.5
It felt comprehensive.
An excellent resource going forward.
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...
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
Webinar was good, informative and lots of information. Speakers are well knowledgeable about Biosimilar Industry.