On July 18, 2018, FDA released its “Biosimilars Action Plan” (“BAP”) for balancing innovation and competition, accompanied by a press release from FDA Commissioner Scott Gottlieb. The BAP marks an important effort by FDA to bolster what Commissioner Gottlieb has characterized as an “anemic” biosimilar market in the United States. As discussed below, both the comments within the BAP and the press release—and the specific BAP deliverables, if realized—could have a significant impact on the biosimilar industry and related litigation.
The BAP has four “Key Elements”:
(1) “Improving the efficiency of the biosimilar and interchangeable product development and approval process”
To support this effort, FDA is developing application review templates specifically for biosimilar applicants and creating a new “Office of Therapeutic Biologics and Biosimilars” to streamline and coordinate review of biosimilar applications. FDA is also developing information resources and development tools, including an “index of critical quality attributes” for comparing biosimilars to reference products. One goal is to reduce the size of clinical studies needed to establish biosimilarity, thereby reducing the time and expense of developing a biosimilar.
(2) “Maximizing scientific and regulatory clarity for the biosimilar product development community”
FDA promises “rapid development of additional guidance” to further clarify the regulatory pathway for biosimilars and interchangeables. As a demonstration of this effort, FDA released final guidance on “Labeling for Biosimilar Products” on the same day as the BAP. FDA also committed to developing an “enhanced Purple Book.” Although FDA did not promise to update the Purple Book with patent information (as in the Orange Book), FDA intends to improve the user experience and include “more information about approved biological products.”
Another key focus will be coordinating efforts with foreign regulatory authorities. FDA is exploring “data sharing agreements that can give us better insight into biosimilars’ real world safety and efficacy and … facilitate the increased use of non-U.S.-licensed comparator products” in studies to support biosimilar applications in the U.S. These non-U.S. comparator products are often less expensive and would decrease the overall cost of developing a biosimilar.
(3) “Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors”
This element is aimed at educating stakeholders about biosimilars and can ultimately reduce the marketing burden on biosimilar developers. FDA has already released educational materials and videos and has hosted a webinar to educate the public. FDA promises to continue these efforts in the future, and use new platforms to disseminate its message.
(4) “Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition”
For this final element, FDA commits to, for example, coordinate with the Federal Trade Commission when it spots anti-competitive behavior. FDA has also suggested it could encourage reference product sponsors to provide samples necessary for developing biosimilar drugs, something that FDA has had success with in the generic drug space.
The BAP and the associated press release allude to potentially anticompetitive behavior in the biosimilar market, some of which has been raised in district court litigation. For example, Commissioner Gottlieb called out “rebating schemes or patent thickets that are purely designed to deter entry of approved biosimilars” as “spoiling” fair market competition. Rebates and contracts are at the heart of the allegations in the antitrust case that Pfizer brought against Janssen related to Remicade® biosimilars. Boehringer Ingelheim has raised unclean hands based on allegedly improper “patent thickets” as a defense in litigation brought by AbbVie over a Humira® biosimilar. Biosimilar litigants may seize upon these statements by Commissioner Gottlieb in support of their positions.
The goals articulated by the BAP may impact the pace of current and future litigation under the BPCIA. For example, accelerating the pace of FDA approval, as envisioned by the BAP, may motivate litigants to push for faster schedules to resolve patent disputes prior to launch. And, preliminary injunction motions may become more common as more biosimilars are approved and the threat of launch is more imminent.
While many of FDA’s new initiatives are designed to help biosimilar developers enter and succeed in the market, Commissioner Gottlieb was careful to emphasize that “[b]iologic manufacturers have a right to defend their legitimate intellectual property interests.” Thus, FDA’s new initiatives are not intended to undermine the proper assertion of patents and we will likely continue to see vigorous patent litigation in this field. Further, at this time, the BAP does not focus on promulgating guidance to clarify the steps of the BPCIA patent dance, which are often extensively litigated in BPCIA litigation and will likely continue to be so.
We will continue to monitor FDA’s efforts in implementing its Biosimilars Action Plan and report accordingly.
Dr. Jenny Shmuel represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and...
Tasha Francis, Ph.D., an associate in Fish & Richardson’s Twin Cities office, practices intellectual property litigation with an emphasis on patent litigation. Dr. Francis has represented plaintiffs and defendants in cases involving medical devices, biotechnology, and...