Biosimilars and Interchangeable Biologics: Are We on the Verge of a Regulatory Watershed?
Food and Drug Law Institute Annual Conference
Healthcare attorney Michael Werner will moderate a panel at the Food and Drug Law Institute (FDLI) Annual Conference titled "Biosimilars and Interchangeable Biologics: Are We on the Verge of a Regulatory Watershed?"
The regulatory landscape for biosimilars is constantly shifting, but an inflection point is rapidly being reached. The U.S. marketplace has not developed as expected, and global differences in clinical study requirements for biosimilarity and interchangeability, along with certain provisions of the Inflation Reduction Act, may affect the future of the industry. Mr. Werner's panel will address this future, including challenges moving forward and what regulatory enhancements could drive biosimilar advancement.
The conference provides in-depth discussions and analysis on a wide variety of timely topics by bringing together experts from the federal government, industry, the private bar, nonprofit, patient and consumer advocates, consulting organizations and academia.