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.
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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
Who Should Attend
This course is perfect for pharmaceutical professionals working in regulation, quality assurance, pharmaceutical development, and R&D, including:
- Regulatory affairs professionals
- Medical affairs professionals
- Clinical development managers
- Quality assurance personnel
- Legal and compliance officers
