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WASHINGTON, DC—Womble Bond Dickinson attorney Dan Orr will be a co-presenter at the “Biosimilars Regulation: Latest Regulatory, Compliance & Approval Developments” webinar.
The webinar will address the FDA’s recent steps to regulate biosimilar competition. Orr will be joined in the discussion by Goodwin Procter LLP attorney Nicholas Mitrokostas.
The 90-minute webinar will discuss such topics as:
- Common problems concerning reference product exclusivity;
- How FDA currently reviews and decides whether to approve a biosimilar application;
- Regulatory and IP considerations and implications of seeking a carve-out of therapeutic indications in the aBLA product label;
- Considerations and implications of using foreign approved products in clinical studies supporting approval of an aBLA, or running clinical trials in foreign countries; and
- Insider insight into FDA’s recently proposed rule and recent guidances.
The Biosimilars Regulation is presented by FDANews and takes place Feb. 14.
Dan Orr is a Partner in the Washington, D.C. office of Womble Bond Dickinson. He advises clients concerning regulatory and patent issues in the pharmaceutical, biotech, and medical device sectors. Before joining WBD 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.
