VIDEOCAST Snapshot of Critical Issues and Challenges in the New Biosimilars Framework
After years of debate, the recent enactment of landmark healthcare legislation included a new regulatory framework for Food and Drug Administration licensure of biosimilar products. Numerous questions have emerged as to FDA's implementation of this important legislation. They range from the potential definitions of key terms to the impact of procedures governing biosimilar applicant challenges to patents for reference biologic products. In this video, the head of Arnold & Porter's FDA and Healthcare practice and the co-head of its Intellectual Property practice provide a high-level review of some of the key issues and challenges associated with the new law.