Programme Day One

Opening remarks from the Chair

William M. Egan, Ph. D. Vice President, PharmaNet Consulting

Follow-on Protein Products: Chemical, Biological, and Clinical Characterization

• A US-centric view of follow-on protein products/biosimilars
• Comparability and Biosimilarity – their historical evolution
• The roles of chemical, biological, and clinical studies in establishing similarity
• The need for clinical studies
• Challenges in establishing efficacy and safety for biosimilars
• Biosimilars and interchangeability: can one exist without the other?

Measuring threats and opportunities of biosimilars – a market barrier for mid-size companies?

• Highlighting the development of your biosimilar intentions from vision to strategy
• Outlining patient developments in a major disease challenge as stimulus to actively enter the biosimilars market
• Exploring the strategic roadmap to success and how to overcome challenges and hurdles
• Identifying key levers on the way to market and how to maximise their impact
• Establishing how to meet payers & customer needs to ensure a successful market share

Case study: overcoming manufacturing challenges of biosimilars – the process defines the product

• Rapid process development strategy for biosimilar product
• Challenges of biological manufacturing – minor changes in the manufacturing process can have major impact on product quality
• Identifying the key issues in ensuring protein drug comparability
• Optimizing manufacturing processes to mitigate risks and ensure biosimilarity

Biosimilars versus biobetters – positioning for a new market with lucrative prospects

• Outlining the benefits of second generation biosimilars (biobetters) over the first-generation products to clearly understand the market
• Uncovering the current biobetter market and underlining the potential with facts and figures
• Identifying the potential of biobetters to be accepted more readily by end-users and over-exceed the originator products revenue
• Overcoming concerns of bioequivalence to make biobetters more attractive to the global health industry
• Learning from Germany how to incentivise biosimilar usage to get access to this lucrative market

Keynote Panel
Are Biosimilars living up to industry and market expectations and what are the factors that will shape their long term future?

• Analyzing their performance to date and establishing key drivers to their changing position in the industry
• Identifying crucial challenges to the growth of the market and pinpointing key steps to maximize growth
• Planning your long-term business strategy: debating the future of the market and identifying the factors likely to influence its development
• Anticipating regulatory developments and how they will impact the market

Exploring successful pricing and reimbursement strategies  in a biosimilar environment

• Understanding key drivers for a successful pricing and reimbursement strategies
• Evaluating value perception of stakeholders and its impact on pricing and reimbursement strategies
• Understanding market access hurdles and how to overcome them
• Forecasting market dynamics and their impact on pricing and reimbursement strategies

Exploring the current legal and IP environment for biosimilars to ensure patent protection for originator and biosimilar products

• Outlining different patent litigation strategies to protect against biosimilars
• Clarifying IP implications and regulatory rules for launching a biosimilar to encourage biogeneric competition and reduce drug prices
• Exploring different regulatory issues to consider when seeking patent protection
• Examining if and which patent strategies apply for biosimilars to clarify the current legal environment
• Optimising your IP strategies for biosimilar life cycle management by taking patent law and regulatory protection into account