BIO and Biosimilars
By Andrew Williams --
The 2011 BIO International Convention in Washington, D.C. begins next week. If you are planning on attending, Patent Docs is highlighting a few sessions, in thematic fashion, to help navigate your way through the convention. Last week, we highlighted four sessions on how the Supreme Court is impacting the BIO community. Today, we present opportunities for those interested in learning more about how the biotech industry is adjusting to the new biosimilar framework. Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#4723 – Hall C).
For BIO attendees interested in learning more about the relatively new pathway for FDA approval of biosimilars, also known as follow-on biologics, there are several sessions devoted to the intricacies of the new law, or how the new legislation is impacting the BIO community. The biosimilar framework was introduced last year in the Omnibus Health Care bill. It is no surprise that biosimilars were a hot topic at the 2010 BIO International Convention, and it continues to garner much interest one year later at this year's convention.
From the perspective of navigating the new biosimilar litigation pathway, the session " A Brave New World: Patent Litigation Tactics and Strategies for Biosimilars," will take place from 3:45 to 5:00 PM on Monday, June 27. This panel will look at the new patent litigation procedure established for FDA approval of follow-on biologics. There are significant differences between the biosimilar pathway and the traditional small molecule Hatch-Waxman model. For example, biologics receive 12 years of data exclusivity instead of five, but the new law discards the Orange Book concept, and instead requires a cumbersome mutual disclosure procedure to foster cooperation and early resolution. The panel will explore different tactical and strategic choices along this new patent litigation timeline. In addition, the session promises to consider questions and concerns that companies face in planning to navigate this new pathway. The panel is well qualified to speak on this subject, because it includes representatives from companies expected to be at the forefront of this new paradigm: Mark Bowditch, Esq., Senior Patent Attorney at Sandoz, Inc., Edward Murray, Managing Counsel, IP Litigation, Merck & Co., Inc., and Bart Newland, Vice President Chief Intellectual Property Counsel, Biogen Idec Inc. This session will be moderated by Eric Marandett of Choate Hall & Stewart, LLP.
In another session, the new framework for FDA licensing of biosimilars will be explored from the perspective of the FDA approach to biosimilar review. " Navigating the New Law on Licensing Biosimilars," will be presented by the Achieving Regulatory Approval and Compliance Track from 3:45 to 5:00 PM on Tuesday, June 28. This panel will look at the meaning of terms such as " highly similar," "interchangeability," and " biobetters," the latter of which are products that present advances over existing products. The scientific challenges that affect regulators and the companies seeking biosimilar approval will be reviewed. And, because biosimilars have been approved in the European Union for more than a decade, the panel will discuss the EU experience, and predict what it may mean for companies seeking approval in the U.S. The panel comprises Rachel Behrman, Director, Office of Medical Policy, FDA; Alison Dennis of Field Fisher Waterhouse, London; Eric Floyd, VP for Global Regulatory Affairs, Hospira; and Kimberly Greco, Director, Regulatory Affairs, Amgen. The session will be moderated by David Adams of Venable, LLP.
To address how follow-on biologics are influencing collaborations between global pharma and biotechs, the session "Lessons From In-Licensing Partnership: Biotech Company Partners with Global Pharma to Deliver Cutting-Edge Follow-On Biologics" will take place from 10:00 to 11:30 PM on Wednesday, June 29. The panel will provide exclusive insight on how global pharma and biotech companies can collaborate to develop, gain authorization, and globally commercialize cutting-edge follow-on biologics. The critical success factors needed to navigate new technology platforms, tech transfers, and global positioning will be discussed. The panel will also describe how to build strong alliances to advance the development of novel therapies. The panel comprises Arun Chandavarkar, Chief Operating Officer of Biocon Ltd.; Stephen Hoge, Principal at McKinsey & Co.; and Diem Nguyen, General Manager, Biosimilars, Pfizer – EM/EPBU Unit. The session will be moderated by Peter Pitts, President of the Center for Medicine in the Public Interest.
Finally, we highlight "Biologics & Biosimilars: What is the Science Telling Us," which will take place from 8:30 to 9:45 on Thursday, June 30, and will explore how science can and should inform the policymaking in the field of biosimilars. The panel notes that policy issues continue to evolve along with the science surrounding biosimilars. As examples, the panel will highlight the U.S. pathway for approval of biosimilars and the issues Europe has faced with the intricacies of Monoclonal Antibodies. The panel promises to discuss emerging scientific issues that are informing policy matters on biosimilars. In addition, the session will provide an update on the key policy and regulatory developments since 2010. The panel comprises Michael Kamarck, President, MerckBioventures, Merck & Co Inc.; Bryan Lian, Executive Director of the Institute of Health Law Studies; and Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations. This session will be moderated by Chris Morrison, Editor-in-Chief, Elsevier Business Intelligence.
Don, Kevin, I didn't stay up to watch the debate on the House floor on HR 1249, which began at around 1 AM my time, but now that I look at C-SPAN, I see that no vote was taken on the bill itself. Do either of you or any of your readers know if the bill is going to come up for a vote in a future House session and if so, when?
Posted by: Daniel Feigelson | June 23, 2011 at 12:30 AM
Dan:
It appears that debate on the bill will continue tomorrow, that votes on individual amendments will be taken tomorrow, and that a vote on H.R. 1249 will take place on Friday. Thanks for the comment.
Don
By the way, your comment gives me an opportunity to promote the Patent Docs Twitter feed (@PatentDocs), where we will continue to provide updates on the patent reform debate.
Posted by: Donald Zuhn | June 23, 2011 at 12:42 AM