20th Biosimilars Congregation 2025

Topics

• Trends & Strategies
  • Market dynamics, challenges, competitive landscape, and emerging ventures
  • Current trends and strategies to access the biosimilar market
  • Barriers to formulary inclusion, health equity, and biosimilar market entry
• Clinical Development
  • Key issues and updates in biosimilar clinical development
• Manufacturing
  • Reducing costs, optimizing development, and navigating pricing pressures
  • Developmental challenges in biosimilar manufacturing
• Research & Development (R&D)
  • Interchangeability studies and enhancements in R&D models
  • Growth in biosimilar R&D, future demand, and success rates
• Market Access
  • Negotiating access, payer influence, and best practices
  • Product launch strategies, sustainability challenges, and market exclusivity
• Regulatory
  • Regulatory shifts, approval pathways, and interchangeability
  • Evolving regulatory framework for biosimilars approval
• Real-World Evidence (RWE)
  • RWE studies, data sources, and market penetration strategies
  • Future evidence requirements for biosimilars registration

Who should Attend

Senior attendees with responsibilities in:

• Follow on Biologics/Follow on Proteins
• Biopharmaceuticals/ Biotherapeutics
• Legal Affairs
• Biologics/Biotechnology/ Biogenerics
• Health Economics
• Intellectual Property
• Clinical Immunology
• Pricing and Reimbursement
• Chief Scientific Officer
• Principal Scientist
• Analytical Characterisation
• Process Control and Analytical Technologies
• Pharmacovigilance
• Regulatory Compliance
• Quality Affairs/ Quality Control
• Drug Safety & Risk Management
• Process Science
• New Product Development
• Research & Development
• Portfolio Management
• Business Operations
• Business Development
• Commercial Affairs
• Scientific Affairs