NEXT WEEK (11/1): The Challenge of Protecting the Public and Promoting Innovation – Dr. Robert Califf, Commissioner, US Food & Drug Administration

robert_califfThe Challenge of Protecting the Public and Promoting Innovation: Dr. Robert Califf, Commissioner, US Food & Drug Administration
Tuesday, November 1, 2016 4:00-5:30
Harvard Kennedy School
Malkin Penthouse, 4th Floor, Littauer Building
79 JFK Street, Cambridge, MA

Robert M. Califf, MD, is the Commissioner of the Food and Drug Administration. He is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. Before joining the FDA in March 2015 as Deputy Commissioner for Medical Products and Tobacco, Dr. Califf ran the Duke Clinical Research Institute. He trained as a cardiologist.

Moderated by Amitabh Chandra, Malcolm Wiener Professor of Social Policy, Harvard Kennedy School

Sponsored by Harvard Kennedy School Healthcare Policy Program, Mossavar-Rahmani Center for Business and Government, Institute of Politics

Biosimilars – In The Pipeline or Still a Pipe Dream?

By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq.

The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of the Affordable Care Act.

Biosimilars are highly similar, but not identical, copies of FDA-approved biologics, known as “reference” products. Biologics are used to treat a variety of diseases and medical conditions, including cancer. For many years, biosimilar development was thought to be too complex and too costly to advance, and exclusivity patents for reference biologics prohibited developers from marketing competing biosimilars. Now that those patents have started to expire, biosimilar development can finally begin, at a potentially huge benefit to patients.

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