In the seven years since the abbreviated pathway for U.S. licensure of biosimilars went into effect, biosimilars have become one of the fastest growing sectors of the pharmaceutical industry. This webinar will cover the Supreme Court’s recent decision on the “patent dance” and its impact on the timing of biosimilar launches and development strategy. The significant regulatory and policy questions regarding the labeling of interchangeable products, reference product exclusivity, and pharmacy substitution policies will also be discussed. Hear from FDA on biosimilar approvals and development programs, along with final, draft, and upcoming guidance documents and learn about the Biosimilars Council efforts to support the industry.
Joe Franklin, Associate Director for Policy, Therapeutic Biologics & Biosimilars Staff, Office of New Drugs, CDER, FDA
Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Christine Simmon, Senior Vice President of Policy and Strategic Alliances, Association of Accessible Medicines and Executive Director, Biosimilars Council
Moderated by John R. Manthei, Partner, Latham & Watkins LLP