Sep 14 2018

Womble Bond Dickinson attorney Daniel Orr has written a new article on the FDA’s latest biologics hearing for the Food and Drug Law Institute. Axinn, Veltrop & Harkrider LLP attorney Brett Garrison edited the article.

Orr writes, “A recent FDA hearing sought to capitalize on the agency’s recent Biosimilars Action Plan, and continued a series of hearings about implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). FDA continues to grapple with many of the same problems such as interchangeability, naming, exclusivity, and transparency that it has since the statute was enacted. But with 12 approved biosimilars behind it and a reported 68 more in development, the agency can also be proud of its progress.”

Click here to read the full article, “Facilitating Competition and Innovation Isn’t Easy: FDA’s Latest Hearing On Biologics” from the Food and Drug Law Institute.

Daniel Orr is a former Regulatory Counsel with the U.S. Food & Drug Administration, where he developed regulatory policy for therapeutic biologics and biosimilars. He is currently a partner in the Washington, DC office of Womble Bond Dickinson LLP and advises primarily pharmaceutical and biotechnology clients.