Tom Hutchings, Consultant, Global Pricing & Market Access and Petra Roos, Senior Director, Clinical Project Management
Biosimilars are generally expected to offer a competitive price advantage to appeal to healthcare organizations and payers which make them an attractive business opportunity. A critical component of market access planning is the ability to communicate an integrated proposition that will alleviate any potential concerns and optimize perceptions of value. Biosimilar developers need to prepare a comprehensive market access strategy. It is important that commercialization success factors are integrated into the strategy at an early stage and are revisited often during development decision making. In preparation for market entry, biosimilar developers must offer a value proposition for their product that resonates with payers and other stakeholders who are influential in access and reimbursement related decisions. This whitepaper provides an introduction into key regulatory and development concerns for sponsors, including a discussion of the factors that affect biosimilar uptake for the United States and Europe and recommendations to address these issues.