Biosimilars: Navigating FDA's Evolving Approval Pathway, Protecting Patents and Trade Secrets

Description

Attention to biosimilars, a biological product similar/interchangeable with another FDA-approved biologic, has increased since the Biologics Price Competition and Innovation Act (BPCI Act) first required the FDA to implement an "abbreviated" approval pathway for biosimilars. The market in biosimilars is forecast to be in the hundreds of billions with many top-selling pharmaceutical biologics scheduled to lose patent protection in the next several years.

With the U.S. falling behind Europe on biosimilar approvals, which will only escalate once the European Medicines Agency finalizes its new guidelines, this convergence of factors sets the stage for firms to launch competitive biosimilars in the next few years. Multinational companies can secure approvals that are currently available in other countries.

Counsel to potential U.S. biosimilar sponsors must prepare to interact with the FDA on its current approach to biosimilars as expressed through a series of draft guidance documents (ver. 4 released in March 2013).

IP practitioners must make their way through the current daunting FDA requirements on requesting, scheduling, conducting and documenting a formal meeting with the FDA under the latest draft guidelines for approving biosimilars. Attorneys must also act to protect trade secrets during FDA review of applications.

Listen as our authoritative panel of IP attorneys explains the FDA's current approach toward approving and regulating biosimilars, outlines challenges that counsel will face, and offers practical approaches. The panel will also examine the complexities of exclusivity, offer best practices for protecting IP and trade secrets in the FDA process, and offer perspectives on patent and exclusivity in developing, marketing and preparing to obtain approval of biosimilars.