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Session 4: Unique Features of Developing Biosimilars in Oncology
Session Chair(s)
Julie Ann Rosenberg, MD
Development Asset Lead, Oncology Biosimilars, Pfizer Essential Health
Pfizer, Inc., United States
Despite availability and known effectiveness of biologic therapies, limited patient access may affect overall patient outcomes. The global cost of cancer care continues to rise, and some healthcare systems ration high-cost treatments. Worldwide access to effective cancer treatments remains an unmet medical need in many countries.
This session will review:
• The evolving therapeutic landscape of oncology and the integration of biosimilars
• Key considerations in clinical trials of biosimilars in oncology
• Extrapolation of indications in Oncology
• Patient views on biosimilars and access to cancer care
• US Regulatory considerations for oncology biosimilars
Speaker(s)
Oncology Biosimilars: A Patient Perspective
Kimberly Wright
Susan G. Komen AIS, United States
Advocate, Embryologist
US Regulatory Considerations for Oncology Biosimilars
Steven J. Lemery, MD, MHS
FDA, United States
Acting Director, Division of Oncology 3, Office of Oncologic Diseases, OND, CDER
Smart Extrapolation Strategy for Biosimilar Rituximab in Oncology
Bernd Liedert
Boehringer Ingelheim Pharma Gmbh & Co. KG Medicine, United States
Biosimilars: An Oncologist’s Perspective
Robert Melvin Rifkin, MD, FACP
US Oncology Reserach, United States
Medical Director- Biosimilars, McKesson Specialty Health
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