With Congress focused intently on the discovery, development, and delivery pipeline for innovative drugs and devices – and in the wake of the first-ever U.S. approval of a biosimilar medication– key policy and regulatory questions are being actively debated, with important implications for industry, patients, and the health care system.
This briefing provided essential background on the U.S. and international markets for reference biologics and biosimilars, outline current policy and regulatory issues, and describe implications for the future, answering questions such as: How are reference biologics and biosimilars regulated, and what are key differences between regulatory frameworks for biosimilars and generic drugs? What can the U.S. learn from the international market for biosimilars? What is the key to balancing innovation and affordability? How do health care providers and patients view the biosimilars market? What does the future hold for the reference biologic and biosimilars markets?
A distinguished panel of experts addressed these and related questions:
Amanda Bartelme, director, Avalere
Sally Howard, J.D., deputy commissioner for policy, planning, and legislation, Food and Drug Administration
Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira
Geoff Eich, executive director, external affairs for Amgen Biosimilars
Ed Howard of the Alliance for Health Reform moderated the panel discussion.
Contact: Sarah Dash, sarahdash@allhealth.org, 202-789-2300
Follow the briefing on Twitter: #biosimilars
