Event Title
Toward Effective Competition in Biologics
Panel
Panel 9: Competition and Compensation
Moderator
Shelly Gulati, Associate Professor, University of the Pacific, School of Engineering and Computer Science
Description
In a previous article—Follow-On Biologics Are Set Up to Fail—I explained why biologics markets do not and probably will not have enough competition. This is not to say that these markets lack competition altogether. Rather, the legal and commercial landscape is such that competition in biologics will remain scant and inadequate for lowering prices of biologics similarly to the price drops seen in generic drugs. This reality is not a result of one or two cardinal reasons, but many. Accordingly, if lowering the price of biologics is the goal and competition is the means by which we seek to achieve this goal, then there does not seem to be a “quick fix” to address all of the many impediments to competition that plague biologics markets. Yet, baring significant technological developments, meaningful competition in biologics markets is not going to be possible without making biologics’ manufacturing information available to follow-on manufacturers.
As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics in general and interchangeable biosimilars in particular is and will continue to be difficult and expensive, if not outright impossible. Yet, it has long been the position of the pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Both Congress and the FDA have subscribed to the Industry’s position and kept regulatory filings submitted by biologics manufacturers, including manufacturing information, unavailable to the public. This article examines the position that manufacturing information is proprietary and must remain confidential in light of the similar legal and commercial circumstances in the area of pesticides. The article reviews the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as it is administered by the Environmental Protection Agency (EPA) and then examines its applicability to the area of biologics. The article proceeds with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.
Location
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
Toward Effective Competition in Biologics
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
In a previous article—Follow-On Biologics Are Set Up to Fail—I explained why biologics markets do not and probably will not have enough competition. This is not to say that these markets lack competition altogether. Rather, the legal and commercial landscape is such that competition in biologics will remain scant and inadequate for lowering prices of biologics similarly to the price drops seen in generic drugs. This reality is not a result of one or two cardinal reasons, but many. Accordingly, if lowering the price of biologics is the goal and competition is the means by which we seek to achieve this goal, then there does not seem to be a “quick fix” to address all of the many impediments to competition that plague biologics markets. Yet, baring significant technological developments, meaningful competition in biologics markets is not going to be possible without making biologics’ manufacturing information available to follow-on manufacturers.
As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics in general and interchangeable biosimilars in particular is and will continue to be difficult and expensive, if not outright impossible. Yet, it has long been the position of the pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Both Congress and the FDA have subscribed to the Industry’s position and kept regulatory filings submitted by biologics manufacturers, including manufacturing information, unavailable to the public. This article examines the position that manufacturing information is proprietary and must remain confidential in light of the similar legal and commercial circumstances in the area of pesticides. The article reviews the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as it is administered by the Environmental Protection Agency (EPA) and then examines its applicability to the area of biologics. The article proceeds with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.
Speaker Bio
Yaniv Heled’s research focuses on legal and ethical aspects of biomedical technologies. He has written on such topics as the regulation of biologics and biosimilars, stem cells, human reproductive tissue, DNA sequencing and testing, and more. His recent notable scholarship includes the article, “Follow-On Biologics Are Set Up to Fail,” which explains why there is not going to be meaningful competition in biologics under current market and regulatory conditions. In another article, “Why Healthcare Companies Should (Be) come Benefit Corporations,” Heled and co-authors, Liza Vertinsky and Cass Brewer, make the case for requiring companies involved in the provision of healthcare products and services to incorporate (or re-incorporate) as benefit corporations, a relatively new type of business entity which is required to consider not only corporate profits but also public health.
Heled is on the faculty of Georgia State University’s Center for Law, Health & Society and is the Co- Director of the Georgia State University Center for Intellectual Property Law. He teaches the courses: Patent Law, Family Law, Law & Biotechnology, Policy & Ethics, and Different & Unusual Forms of Intellectual Property.
Prior to joining Georgia State Law, Heled practiced intellectual property law with Goodwin Procter LLP in New York.
Heled earned a J.S.D. from Columbia University School of Law. His doctoral dissertation focused on the regulation of novel biomedical technologies. In addition, Heled holds an LL.M. from Columbia, where he was a Harlan Fiske Stone Scholar, and an LL.B. and undergraduate Diploma in Biology, magna cum laude, from Tel Aviv University.