12^th Asian Biologics and Biosimilars Congress

When preparing to launch a biosimilar, key distinctions from traditional biologic product launches and increased uncertainty across regulatory, legal and commercial spheres make navigating this landscape especially challenging. It is critical to align incentives of key stakeholders (providers, patients, payers, pharmacists and procurement) as they each can play a critical role in driving/delaying biosimilar uptake. Achieving commercial success in biosimilar’s therefore requires a new approach to understand the market complexity and to engage these stakeholders. Biosimilar developers need to have a strategic plan for forecasting and market research to e ectively maximize the commercial opportunity. Forecasting biosimilar uptake

can be daunting as market events can result in dramatic swings in expected uptake. As a result, a biosimilar forecast should not be an exercise of determining a single share point or uptake curve -rather it should be about understanding the scenarios that could unfold the forecast in each scenario and understanding the key drivers that will determine the success or failure

of a biosimilar. Market research can identify opportunities a manufacturer (innovator or biosimilar) can in uence across stakeholders. Faced with this paradigm shi , manufacturers have struggled to understand the right questions to understand the complexities of the market some they should consider: (1)What are the key drivers and barriers to uptake across stakeholders?

(2) What levers are most successful at encouraging biosimilar adoption? (3)What archetype markets are most appropriate to use as analogs? (4) How can biosimilars di erentiate themselves when clinical di erentiation is not possible? (5) What are the most successful contract pricing strategies in a market with biosimilar competition? These questions are critical to address

through tailored research techniques and modeling to e ectively map the interplay of the incentives of each stakeholder type.