FDA Approval Options for Follow-On Biologicals
- Paul A. Calvo & Timothy J. Shea, Jr.
- World Intellectual Property Review
Parties seeking to market a follow-on biological product in the US traditionally have had two options for obtaining Food & Drug Administration approval of their product. With the passage of the Biologics Price Competition and Innovation Act last year, there is now a third option. Paul Calvo and Timothy Shea explain the key advantages and disadvantages of each. Download the PDF for the full article.