Conference Agenda
14th Biosimilars Global Congress 2022 Europe
Day 2: Tuesday 8th November 2022
08:00 am - Conference Registration and Continental Breakfast
08:50 am - Chairperson’s Welcome and Opening Remarks
Current Regulatory Landscape
09:10 am Opening Session: The Evolution of Biosimilars: First decade and Beyond > How Europe has steamed ahead while America is still in first gear
- Critical aspects of the global Biosimilar market such as vendor landscape, competitive strategies, market drivers and challenges
- Changing market dynamics within the Biosimilars market
- The (relatively) welcoming EU environment vs. the US quagmire
- The patent dance - or the last waltz for US biosimilars?
Peter Wittner, Senior Consultant, Interpharm Consultancy
9:40 am - Biosimilars and the law in the EU/UK
- EU law supporting biosimilars in the EU, and the basis for EU approvals.
- The main EU guidelines.
- Biosimilars post-Brexit.
Ray Cresswell, Pharmaceuticals and Biotech Lawyer
10:10 am - Phase 3 studies in Biosimilars: Does it tell us enough to be useful?
- Do they add to our knowledge about the safety and efficacy of biosimilars?
- Phase 3 Studies in Biosimilars: Statistically Speaking
- More Pressure on Postmarketing Surveillance
Cecil Nick, Vice President (Technical) PAREXEL
10:40 am - Morning Networking & Refreshment Break
Access, Collaborations and Commercial Strategies
11:20 am - High Uptake. Low Prices. A Discussion of the Danish market for Biosimilars
- The ways to a high uptake: Five essentials
- Belief in Science
- Health Authorities
- Procurement, Tenders and Pricing
- Stakeholder participation
- Information to patients
- A miracle - or just common sense and cooperation?
Peter Jørgensen, CEO, The Danish Generic and Biosimilar Medicines Association
11:50 am - Biosimilars – from acceptance to sustainability
- Current Environment is constantly changing
- Health systems are seeing the benefits
- Patient impact should be a major consideration
- How do we keep competition in the market
Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency*
12:20 pm - Patients perspectives on Biosimilars
- Significantly invest in the training of medical professionals, including nurses
- Develop patient information/assistance programs
- Partner with patients’ organizations and regulators
- Economically incentivize patients to accept a biosimilars prescription
- Consider patients as partners, and no longer as “subjects”
Xavier Fraise, Principal, F.-X. Frapaise Pharma Consulting, Former VP. Clin Dev. Merck
12:50 pm - Networking Lunch
1:50 pm - Panel Discussion: Review of the impediments to biosimilar development and commercialisation and addressing them to realize its full potential
- Contracting and rebates practices by reference products manufacturer
- High manufacturing complexities, development costs and market uncertainties
- Delay in regulatory pathway and rigorous regulatory requirements
- Lack of information and experience among healthcare professionals and patients
Moderator:
Yariv Hefez, VP, Global Head Oncology Marketed Products, Merck Group
2:20 pm - EU Payers perspective that will impact adaptation, pricing and reimbursement of biosimilars
- What are the trends driving adoption, pricing and reimbursement?
- Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access
- Current climate for price discounting, is a uniform price possible
- Increasing role of patient group whose voices are to be heard
2:50 pm - Current trends in Market Access: Challenges and Potentials
- What are the trends driving adoption, pricing and reimbursement?
- Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access
- Current climate for price discounting, is a uniform price possible
- Increasing role of patient group whose voices are to be heard
3:20 pm - Afternoon Networking & Refreshment Break
4:00 pm - Regulatory and Commercial Considerations of Developing Biosimilars in Emerging Markets
- Regulatory and clinical considerations in emerging markets
- Operational issues in emerging markets
- Biosimilar trends in Emerging market
- Challenges and opportunities in emerging market countries
4:30 pm - Closing Panel Discussion: Stakeholder collaboration to increase market uptake of biosimilars
- Strategies for overcoming barriers to biosimilar adoption
- How can biosimilar developers, patients, healthcare proffesionals and payers conspire to establish a sustainable biosimilar market
- Importance of Physician and Patients input in shaping international standards for
- biosimilars
- Policies in place to encourage physicians / pharmacist collaboration
- Commercial potential and best ways on how to gauge such an opportunity in biosimilar
5:10pm - Chairperson's Closing Remarks