WASHINGTON, D.C.—Womble Bond Dickinson attorney Daniel Orr will join a panel discussion titled Biosimilars: New Developments and Updates. The panel discussion is part of the Food and Drug Law Institute Annual Conference and takes place May 3 at the Ronald Reagan Building and International Trade Center in Washington, D.C.
Panelists will discuss developments concerning biosimilars in the past year. Dan will speak concerning reference product exclusivity for biological products, and the transition provisions of the Biologics Price Competition and Innovation Act that will convert certain products currently regulated as drugs into biologics on March 23, 2020.
Other members of the panel will include:
- Joseph Franklin, Associate Director of Policy for Therapeutic Biologics and Biosimilars, U.S. Food & Drug Administration
- Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
- Bruce A. Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals
Daniel Orr is a Partner in the Washington, D.C. office of Womble Bond Dickinson. He advises clients concerning regulatory issues in the pharmaceutical, biotech, and medical device sectors. Before joining Womble in January 2018, Dan was a Regulatory Counsel in FDA’s Center for Drug Evaluation & Research where he solved regulatory problems in a portfolio of drugs and biologics with combined annual sales of more than $37 billion. Dan was the Regulatory Counsel assigned to three of the nine biosimilars that FDA has approved to date, and worked on many of the Agency’s guidance and proposed rules related to biosimilars. He also served on the CDER Exclusivity Board and was the subject-matter expert concerning reference product exclusivity for biological products.