Paradise Jordan
Seton Hall University School of Law, Newark, New Jersey, USA.
Seton Hall Law Rev. 2011;41(2):501-10.
This Book of the Seton Hall Law Review presents the contributions to Follow-On Biologics: Implementation Challenges and Opportunities, a one-day roundtable event hosted by Seton Hall University School of Law in the fall of 2010. The roundtable fostered an international dialogue regarding the future of follow-on biologics in the United States resulting from the Patient Protection and Affordable Care Act of March 2010. THE BIOLOGIC PRICE COMPETITION AND INNOVATION ACT OF 2010. The March 23, 2010, enactment of the Patient Protection and Affordable Care Act (PPACA) and the companion Health Care and Education Affordability Reconciliation Act of 2010 ushered in landmark reform of the American health care system. Along with sweeping overhauls of the health care system generally, PPACA also provides a new regulatory challenge for the Food and Drug Administration (FDA). A subtitle within PPACA, the Biologics Price Competition and Innovation Act (BPCIA), bestows upon FDA broad authority to implement an abbreviated approval route to market for biological products (also known as biologics) that are "biosimilar" to an existing marketed product. The brief introduction will provide a basic comparison of biologics and conventional pharmaceutical drugs that will prove central to the FDA's development of this follow-on biologic pathway as well as specifically examine the content and scope of the BPCIA provisions and identify future challenges for the FDA. It will conclude by highlighting details of presentations during the roundtable held at the Seton Hall University School of Law and introduce the two resulting articles contained with this Book of the Seton Hall Law Review.
《西顿霍尔法律评论》的这本书呈现了对“后续生物制品：实施挑战与机遇”的贡献，这是西顿霍尔大学法学院于2010年秋季主办的一场为期一天的圆桌会议。该圆桌会议促成了一场关于2010年3月《患者保护与平价医疗法案》所引发的美国后续生物制品未来的国际对话。2010年生物制品价格竞争与创新法案。2010年3月23日，《患者保护与平价医疗法案》（PPACA）以及配套的2010年《医疗保健与教育可负担性协调法案》的颁布开启了美国医疗保健系统的里程碑式改革。除了对医疗保健系统进行全面改革外，PPACA还给美国食品药品监督管理局（FDA）带来了新的监管挑战。PPACA中的一个副标题，即《生物制品价格竞争与创新法案》（BPCIA），赋予FDA广泛权力，为与现有已上市产品“生物类似”的生物制品（也称为生物药）实施一条简化的上市批准途径。简短介绍将对生物制品和传统药物进行基本比较，这对于FDA制定这条后续生物制品途径至关重要，还将具体审视BPCIA条款的内容和范围，并确定FDA未来面临的挑战。最后将着重介绍在西顿霍尔大学法学院举行的圆桌会议期间的发言细节，并介绍《西顿霍尔法律评论》这本书中收录的两篇相关文章。
