BIO and Biosimilars
By Andrew Williams --
The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large amount of information and opportunities available can appear daunting at first glance. To assist our readers, we recently provided information about the convention, and listed sessions that might be of interest to Patent Docs readers. In addition, with this post, we begin a more in-depth series of previews highlighting a few sessions or other opportunities, in thematic fashion, to help navigate the convention. Of course, as we previously reported, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent. Patent Docs readers are encouraged to stop by the MBHB booth (#504) to discuss these sessions (or whatever other topics are of interest to you).
One topic that is sure to be on the minds of many of the patent practitioners in the biotech and pharmaceutical space is the increased usage of the Biologics Price Competition and Innovation Act ("BPCIA"). Last year at this time, Sandoz had already obtained approval to market the first such drug, Zarxio™, which is a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic drug product. At the same time, the Federal Circuit was sorting out whether two aspects of the BPCIA were either mandatory or optional: (1) the disclosure and patent exchange provisions (the so-called "Patent Dance") and (2) the Notice of Commercial Marketing provision. The Court ultimately held that the first was optional but the second was mandatory (at least in cases where the biosimilar applicant did not participate in the patent dance). This year, we are in a similar situation in the biosimilar space. The FDA has recently approved its second biosimilar application, this time Celltrion's application for a biosimilar therapeutic antibody related to Janssen Biotech Inc.'s REMICADE® (infliximab). However, the Federal Circuit is again considering whether the Notice of Commercial Marketing is required, this time in the context where the biosimilar applicant disclosed its aBLA. Interestingly, that case does not relate to Celltrion's application, but instead arose from a litigation related to an aBLA filed by Apotex directed to Amgen's NEULASTA® (pegfilgrastim).
Last year, the Intellectual Property track at the BIO convention did not contain any sessions focused directly on the BPCIA, likely because the pathway had not been utilized in the preceding years since the BPCIA was enacted. This is not the case this year. In fact, the session that will kick off the Intellectual Property track is entitled "Rise of the Biosimilars: Recent Developments and Strategies for Innovators and Biosimilar Applicants for Resolving Patent Disputes Under the BPCIA." The description of the session notes that the process for resolving patent disputes under the BPCIA was modeled after the Hatch-Waxman Act, but that there are substantial differences which have allowed biosimilar applicants to pursue varied approaches. As such, the panel will explore the recent legal developments, and will discuss strategies from both the innovators and biosimilar applicant perspective. The speakers on the panel will be Christof Bull, Associate General Patent Counsel of UCB; Charles Sholtz, VP of Intellectual Property at Coherus Biosciences; and Immac (Casey) Thampoe, Managing Counsel, Biologics & Vaccines at Merck & Co., Inc. The session will be moderated by John Labbe of Marshall Gerstein & Borun LLP.
Of course, the Intellectual Property issues related to biosimilars are not the only roadblock to patient access to these follow-on drugs. For those interested in these issues, the Value, Patient Access, & Commercialization track will host a session entitled "The Future of Biosimilars: How Will Policy and Market Dynamics Impact Patient Value and Access in the US?" The description of this session highlights the fact that, unlike small-molecule generic drugs, biosimilars are not automatically interchangeable. The complex and expensive process for manufacturing these drugs may impact any potential cost reduction. Moreover, there is concern over how payers will structure biosimilar policies. This could impact patient access to branded biologic drugs, and could impact long-term innovation in the biopharmaceutical space. The panel will address questions such as whether formulary restrictions will direct patients away from innovator products, what role will the FDA's guidance regarding interchangeability impact these decisions, and what sort of post-market surveillance will be implemented to ensure safety and efficacy of biosimilar drugs. The speakers will be Kathleen Arntsen, President/CEO and Patient Advocate of Lupus and Allied Diseases Association; Geoffrey Eich, Executive Director of External Affairs and Biosimilars at Amgen; Darius Lakdawalla, Quintiles Chair in Pharmaceutical Development and Regulatory Innovation at the University of Southern California; and Tomas Philipson, Professor at the University of Chicago. The session will be moderated by Dana Goldman, Leonard D. Schaeffer Director's Chair at the University of Southern California Leonard D. Schaeffer Center for Health Policy & Economics.
The Value, Patient Access, & Commercialization track will also host a session related to the impact of the rise of biosimilars in Europe. Entitled "Biosimilar Medicines: Creating Sustainable Competition in an Era of a New Patent Cliff in Biological Medicines," this session will look at how European governments have worked to ensure competition in pharmaceutical markets that are no longer protect by patents. The industry itself believes that the sustainability of the healthcare systems hinges on access to new treatments and competition. As such "[c]ompetition between different biological medicines . . . creates increase choice for patients and clinicians, and enhanced value propositions for individual medicines." In this session, IMS Health will present a study that analyzes the uptake of biosimilar medicines and their impact in the European Member States. The panel will discuss the goals and challenges of solving health inequalities and improving access to medicines for patients already undergoing treatment. The speakers will be Douglas Gregory, Executive Director, European Union Government Affairs at Amgen; Gregory Oakes, Vice President and Head of Biopharmaceuticals at Sandoz; and Per Troein, VP Strategic Partners at IMS Health. The panel will be moderated by Hilda Juhasz, Policy Officer at the European Commission in Brussels, BE.
Please be on the look-out for future preview posts, and we look forward to seeing you next week at BIO 2016.
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