The Road Ahead: Managing IP and Addressing the Regulatory Issues of Biosimilars

With the signing of the Patient Protection and Affordable Care Act the biotechnology community now has a clearer view of the road to approving Biosimilars. Such clarity, however, has given way to new questions on the FDA’s standards for Biosimilar products and how this new approval process will impact the business of innovative biotech. One thing is for certain, that this emerging industry can no longer be denied with an estimated global market totaling over $20 million.

In this session panelists will provide:

• Insights on how Biosimilars may impact current product portfolios
• Techniques for developing a secure patent portfolios
• Strategies for early and late stage biotech companies in creating business models that address the challenges and opportunities created by Biosimilars
• Navigating the regulatory process from both the applicant and BLA holder perspectives
• Discussion on how Biosimilars have impacted the biotechnology investment community

Panelists:

• Nathan Beaver, Partner, Foley & Lardner LLP
• Douglas Carsten, Partner, Foley & Lardner LLP
• Dr. Sami Guzder, Chief Scientific Officer, Avesthagen Limited
• Jeffrey W. Winkelman, Ph.D., J.D., Vice President, Oncology Programs, BioSante Pharmaceuticals