Biosimilars Training Course - May 21-22, 2025

Prepare for the biosimilar market growth as some of the world’s best-known biologics face patent expiration in the coming years.

Learn more: https://bit.ly/4hsFnXS

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

Agenda

Day 1

Biologics introduction

• Technical and legal definitions
• Examples of biologics
• The complexity of biologicals
• The challenges with development of biologics

Biosimilars vs generics

• How the process is the product
• A simple excursive to be reminded of the difference between biosimilars and generics
• Creating a copy with limited and imperfect tools

The (e)CTD

• International council of harmonization (ICH)
• The common technical document
• CMC explained (incl. quality by design, specifications)
• Why the CMC section for biologics is more extensive (as compared to small molecules)

The (e)CTD continued

Day 2

The registration process

• A review of EMA and FDA biosimilar guidelines
• Biosimilar development as a step-wise approach
• Quality
• Non-clinical
• Clinical
• Non-comparable biologics
• Other regulatory topics
• Interchangeability
• Naming
• Labelling
• Pharmacovigilance

Module 3 for biosimilars - section by section

• In-depth review of module 3 documentation with special remarks regarding biologics and biosimilars specifically

Challenges for biosimilar sponsors

• Global development
• Costs
• Uncertainty

Main players in the biosimilar field

• A review of the current situation

Strategic considerations

• A summary of key points to consider when (starting to) develop biosimilars

Case study

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?