The Evolving Biosimilars Landscape: A Medical Affairs Perspective
Bryan Katz, MBA
Syneos Health, United States
No matter what position a company plays in the biopharmaceutical market (innovator or not), biosimilars will bring new challenges. The key challenge companies must face is how they will adapt their product development and commercialization strategies to be successful. Manufacturers have started to realize that biosimilars require not only a unique development pathway but also a more tailored go-to-market approach. While much has been said about the need to modify the commercial support required for biosimilars, the role of medical affairs and how it needs to evolve to guide biosimilar product development strategy is yet to be defined. Similarly, the role of medical affairs in shaping defense strategies in the face of biosimilar competition has not been explored. This session will analyze three key challenges to the development and commercialization of biosimilars: 1) regulatory uncertainty; 2) development complexity; and 3) lack of stakeholder confidence and will discuss how medical affairs is uniquely positioned to help manufacturers address these challenges and how this function can evolve to better serve pharmaceutical companies.
Learning Objective : Describe the three key challenges to biosimilars development and commercialization; Discuss how medical affairs is uniquely positioned to help address those challenges; Identify how medical affairs is organized in this growing field.
Medical Affairs Perspective
Gary Fanjiang, MD, MBA, MS
Executive Medical Director, Biosimilars
Amgen, United States