Biosimilars: Will there be new legislation this year? What would it mean for the biotech industry?
During the past few legislative sessions, Congress has been considering adoption of a regulatory pathway that would allow for FDA approval of "follow-on biologic" products, or "biosimilars." Questions surrounding the safety of such products, patent protection, and the length of data exclusivity periods lie at the heart of this debate. This teleconference reviews the key provisions of the most recent proposals for biosimilar legislation and the implications for the biotech industry if they become law.