The Biosimilar Action Plan–An Effective Mechanism for Balancing Innovation and Competition in the United States?
Panel
Panel 12: Biologics, Biosimilars, and Data
Moderator
David Collum, Associate Clinical Professor and Chair, Entrepreneurial Program, University of the Pacific, Thomas J. Long School of Pharmacy and Health Sciences
Description
The strain between balancing pharmaceutical innovation and competition in the U.S. is centered around the need to ensure that the U.S. continues to encourage medical innovation without sacrificing the ability to provide patients with access to innovative drug treatments. This need is as important for traditional chemically-based drug treatments as it is for more complex drugs, such as biologics. In July 2018, the U.S. Food and Drug Administration issued the Biosimilar Action Plan (the Plan)-its most recent attempt to successfully strike this balance for biologics. Increasing biosimilar informational resources and streamlining the FDA application and approval process was one of the Plan’s four “priority deliverables.” The Plan appears effective at incentivizing biosimilar product development, as evidenced by the over 60 biosimilar development programs ongoing and the record number of biosimilar products approved by the FDA in 2018. However, the FDA acting alone lacks the bandwidth to implement the priority deliverable that has the greatest impact on lowering biosimilar drug costs and increasing patient access: “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.” Partnerships with key stakeholders, such as the Federal Trade Commission, Congress, Non-Governmental Organizations, and Payors are crucial to achieving this goal. The recently proposed Biologic Patent Transparency Act is a work-in-progress that demonstrates how Congress can work in tandem with the FDA and others to foster competition and build a sustainable biosimilar marketplace for patients in the U.S.
Location
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
The Biosimilar Action Plan–An Effective Mechanism for Balancing Innovation and Competition in the United States?
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
The strain between balancing pharmaceutical innovation and competition in the U.S. is centered around the need to ensure that the U.S. continues to encourage medical innovation without sacrificing the ability to provide patients with access to innovative drug treatments. This need is as important for traditional chemically-based drug treatments as it is for more complex drugs, such as biologics. In July 2018, the U.S. Food and Drug Administration issued the Biosimilar Action Plan (the Plan)-its most recent attempt to successfully strike this balance for biologics. Increasing biosimilar informational resources and streamlining the FDA application and approval process was one of the Plan’s four “priority deliverables.” The Plan appears effective at incentivizing biosimilar product development, as evidenced by the over 60 biosimilar development programs ongoing and the record number of biosimilar products approved by the FDA in 2018. However, the FDA acting alone lacks the bandwidth to implement the priority deliverable that has the greatest impact on lowering biosimilar drug costs and increasing patient access: “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.” Partnerships with key stakeholders, such as the Federal Trade Commission, Congress, Non-Governmental Organizations, and Payors are crucial to achieving this goal. The recently proposed Biologic Patent Transparency Act is a work-in-progress that demonstrates how Congress can work in tandem with the FDA and others to foster competition and build a sustainable biosimilar marketplace for patients in the U.S.
Speaker Bio
Simone Rose is the Associate Dean for Innovation and Entrepreneurship at Wake Forest University School of Law, an award-winning professor and active scholar who writes and publishes in the area of intellectual property (IP). Her scholarship explores whether the current incentive-centered framework of IP law meets the Constitutional mandate to “promote progress” and effectuates the proper balance between incentivizing innovation and public access. Through a series of articles she challenges us to engage in a more holistic view of progress which allows us to evaluate the impact of patent, trademark and copyright laws on future writings and discoveries, humanism, morality and the environment. Simone enjoys mentoring junior colleagues on how to maintain an “innovative” mindset in both their teaching and scholarship as well as sharing scholarly and teaching ideas at various workshops and conferences.
Prior to joining the law faculty, Simone practiced law at Foley and Lardner LLP. As a registered patent attorney, she assisted clients in both the acquisition and enforcement of patent, trademark and other intellectual property rights. Simone is a board member and ardent supporter of Tri-City Relays/Project T.E.A.C.H. which stands for “teaming education with athletics to create hope”. She also lives her passion for enhancing the law school’s teaching and learning environment by chairing the faculty committee on Academic Engagement. As Associate Dean for Innovation and Entrepreneurship, Simone continues to increasing the law school’s presence and participation in multidisciplinary platforms within the University and in Winston-Salem’s Innovation Quarter.