BioPharm Int’l recently published a nice overview of where the FDA debate is on biosimilars. Highlights:
- There is broad support for legislation which clarifies the path for biosimilars to be developed.
- Innovator companies and generic companies are, as expected, far apart on issues such as data exclusivity, preclinical and clinical trial requirements, and other issues
- Biosimilars may be “similar” but may not be interchangeable. It is possible that the concept of AB Ratings for oral small molecules will not be possible for biosimilars
We do not envy the task before the FDA next year. The FDA will have to make some difficult decisions to balance the need to reduce the costs of biologics while at the same time preserving the desire of innovators to remain on the market for as long as possible.