The American Conference Institute (ACI) held its 8th annual summit on biosimilars in New York City to discuss the latest developments in the field. ACI chose its timing well, as the Supreme Court released its opinion in the Amgen v. Sandoz case during the first morning of presentations. Thought leaders present at the symposium reacted in real-time to the decision, and stimulating conversations followed into the evening. Below is a summary of some key discussions that took place at the meeting.
The conference opened with a panel discussing policy and politics under the new administration. Drug pricing was one of the most important considerations, especially given statements by the new administration indicating that it would be targeting high drug prices in the near future. The panel reviewed and provided updates on proposed legislation affecting biosimilars and drug pricing, including the FAST Generics Act of 2017 (H.R. 2051), CREATES Act of 2017 (S. 974), Affordable and Safe Prescription Drug Importation Act (S. 469) and the Improving Access to Affordably Prescription Drugs Act (S. 771 and H.R. 1776).
A key topic of discussion was the recent decision in Amgen v. Sandoz, with panelists and the audience trying to process the ramifications of the Court’s ruling. As one panelist noted, it is now clear that the biosimilar applicant significantly controls the process of patent resolution under the BPCIA. Others noted that biosimilar applicants will likely take into account situation-specific considerations, including number of patents at issue, strength of patents at issue, and time to market, in considering whether or not to engage in the BPCIA’s patent dance.
Panelists also provided updated statistics on biosimilar activity to date. As of May 2017, 15 biosimilar applications have been filed with the FDA, and 5 have been approved. A sixth approval is anticipated shortly, since the FDA Advisory committee recently recommended approval of Pfizer’s Epogen®/Procrit® biosimilar. The average time to FDA licensure has ranged from 10-20 months from the time the aBLA was accepted for review. Of the remaining aBLAs accepted for review at this time, most are for filgrastim or pegfilgrastim, posing significant challenges to Amgen’s Neupogen® and Neulasta® market share. Two biosimilars (Zarxio and Inflectra) have hit the United States market, with about a 10-15 percent reduction in price compared to the reference drug and a similar percentage of market share to date. No interchangeables have been approved, and the panelists were not aware of any interchangeable applications filed at the FDA.
Another panel tackled the topic of untangling the inner workings of IPRs in the biologics space. Panelists commented on how the biopharma industry was slow to enter into IPR proceedings, but there has been steady growth since 2013. Method of treatment patents were identified as those most susceptible to IPR review, with formulation patents being the second most popular.
As biosimilars come to market, additional legal issues have come to the fore, including potential product liability concerns. Although to date no such litigation has been initiated, panelists addressed potential product liability considerations in the biosimilar context. For example, the differences in labelling requirements under Hatch-Waxman and the BPCIA could raise unique concerns for biosimilar manufacturers in failure to warn cases: federal preemption, which arises in the generic context because generic labels are generally limited to the brand label, may not arise in the biosimilar space where the FDA guidance allows and encourages biosimilar labels to depart from the reference product label in certain critical respects.
Other topics included ethics and professional responsibility concerns for the biosimilars industry, judges’ perspectives on biosimilar litigation, biosimilar naming conventions, and pricing and reimbursement issues for biosimilars.
Overall, the conference highlighted how the U.S. biosimilar market is growing and how the legal issues involved are evolving in real-time. As a result, many legal, regulatory, and commercial questions surrounding the emerging U.S. biosimilars landscape remain unresolved. We will continue to actively monitor these issues and provide updates in our future blogs.
Authors: Jenny Shmuel, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
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 has examined and...