May 29, 2019
Harvard Medical School
Welcome to our expert roundtable on biosimilar insulin. Insulin was originally isolated and used in clinical care about 100 years ago, with the key scientists famously donating the intellectual property for $1 each so that "anyone would be free to prepare the extract, but no one could secure a profitable monopoly." Since then, there have been a number of important improvements to the insulin product, and currently millions of people around the world depend on various forms of insulin to manage their diabetes. However, in recent years, there have been concerns about the high costs of insulin, which have led to impediments to access and disastrous patient outcomes, and have also strained limited health care resources. In response, many have asked why insulin remains without low-priced "generic" alternatives, which are common in nearly every other class of drugs with such a long history. In this meeting, we will discuss a number of the key scientific, regulatory, and clinical issues facing the production, dissemination, and use of inexpensive insulin. We have brought together experts from academia, industry, the patient advocacy community, and government to share their perspectives. How can we work together to promote availability of low-cost insulin? What are the main hurdles and what additional research is needed?
Co-hosted by PORTAL and the Harvard-MIT Center for Regulatory Science.
Session I: Clinical Considerations
Kasia Lipska, Yale University School of Medicine
Teodorina Lessidrenska, T1 International
Session II: Market Considerations
Surya Singh, Singh Health Advisors
Elizabeth Jex, Federal Trade Commission (Remote)
Session III: Scientific/Regulatory Considerations
Cory Wohlbach, Teva Pharmaceuticals
Eva Temkin, Food and Drug Administration
Session IV: Discussion Synthesis
Brainstorming: Next Steps