While the pathway for biosimilars has been determined as well as the length of market exclusivity for reference products, as the FDA begins to implement the new Act many issues related to execution and operations will surface as these new procedures and regulations are put into action.
This Web conference reviewed certain FDA issues such as:
- When will the FDA begin accepting applications?
- Can applications be submitted before user fees are established?
- What are the data requirements?
- How can applicants demonstrate that there are no meaningful clinical differences in terms of safety, purity, and potency?
In addition to the regulatory issues, achieving clarity related to patent dispute procedures may be challenging. The new biosimilar legislation establishes a new, complex procedure for resolving patent disputes based on a biosimilar application, and defines an applicant’s challenge to patents as an act of infringement.
This Web conference also outlined relevant details of such patent related issues and questions still outstanding and provided insight on how life sciences companies can plan for the new regulation and process in both the short- and long-term.
Foley speakers:
- Jackie Wright Bonilla, Partner, Foley & Lardner LLP
- Nate Beaver, Partner, Foley & Lardner LLP
- Kristel Schorr, Senior Counsel, Foley & Lardner LLP
The Pathway Cleared for Biosimilars? A Guide for the Road Ahead is part of the Health Care Reform: What’s In It For The Life Sciences Industry Web Conference Series.