Overview
While FDA has made tangible progress in reviewing and approving applications for biosimilars, there are still significant barriers for sponsors attempting to access and succeed in the market. In this webinar, panelists will review the current roadblocks to a robust biosimilar market in the US, including regulatory approval challenges, patent litigation risks, and whether there is hesitancy to accept biosimilars as equivalent to their biologics counterparts by doctors, patients, and payers. Panelists will also discuss proposed and potential changes to the current system that could improve access to and use of biosimilars
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Speakers
Eva Temkin, Associate Director for Policy (Acting), Office of Therapeutic Biologics and Biosimilars, CDER, FDA
Rachel Turow, Associate General Counsel, Regulatory Law & Policy, Teva Pharmaceuticals USA, Inc. and Member, FDLI Board of Directors
Michael Werner, Partner, Holland & Knight LLP
Moderated by John R. Manthei, Partner, Latham & Watkins LLP
EVA TEMKIN is the Acting Director for Policy in the Office of Therapeutics and Biologics within FDA’s Center for Drug Evaluation and Research. In this role, she oversees the development and implementation of policy related biological products, including biosimilar and interchangeable biologic products. As agency lead for FDA’s Biosimilar Action Plan, which outlines the Administration’s plans for encouraging innovation and competition among biologics and the development of biosimilars, Ms. Temkin works on a variety of subjects related to competition and patient access. Prior to joining the Office of Therapeutic Biologics and Biosimilars, Ms. Temkin was Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, providing counseling to Agency components working on numerous biomedical products issues, ranging from expedited pathways and questions of data development and evidentiary standards to over-the-counter monograph reform. Previously, Ms. Temkin was a litigator at the law firms of Cravath, Swaine & Moore LLP and Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP and a law clerk in the United States District Court for the Eastern District of New York. She earned her JD from New York University School of Law, where she was the NYU Law and Economics Fellow, and her BA in economics from the University of Michigan.
RACHEL TUROW is Associate General Counsel, Regulatory Law & Policy and Head, U.S. Regulatory Policy at Teva Pharmaceuticals USA, Inc. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects. Rachel also serves as Head for U.S. Regulatory Policy where she leads policy advocacy on key areas for Teva’s R&D activities as well as Teva’s U.S. trade association interactions. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA. She was a Regulatory Counsel in CDER’s Office of Regulatory Policy and she served as Special Assistant to Jeff Shuren, Director of CDRH. Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from Stanford University. 
MICHAEL WERNER is a Washington, DC-based public policy and regulatory attorney and a co-leader of Holland & Knight’s Healthcare & Life Sciences Team. Mr. Werner has almost three decades of healthcare law, lobbying, regulatory, and reimbursement experience in Washington. He focuses on issues affecting FDA-regulated entities, including biotechnology and pharmaceutical companies developing and manufacturing prescription and over-the-counter (OTC) drugs, biosimilars, cosmetics, dietary supplements, and digital-health technologies. His specific areas of knowledge include FDA regulations regarding product approval, marketing, and distribution; Medicare, Medicaid, and commercial insurance reimbursement; regulation and reimbursement of cell therapy, gene therapy, tissue engineering, and regenerative medicine products; the Physician Sunshine Act; human subject protection issues such as institutional review board (IRB) review and informed consent; as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies. Mr. Werner is the co-founder and senior policy counsel of the Alliance for Regenerative Medicine, the leading global organization representing the cell therapy, gene therapy, tissue engineering, and regenerative medicine sector.
JOHN R. MANTHEI, Global Chair of Latham’s Healthcare & Life Sciences Practice, focuses his practice on regulatory matters involving the US Food and Drug Administration (FDA) for the medical device, pharmaceutical and biotechnology industries. He advises clients on all aspects of the FDA-regulated product life cycle, post market enforcement, and administrative litigation. Mr. Manthei currently serves as outside FDA counsel to the Medical Device Manufacturers Association (MDMA), a member of the Food & Drug Law Institute (FDLI) Advisory Committee for Medical Devices, and a former member of the FDLI Advisory Committee for Drugs and Biologics. He previously served as Majority Counsel for the US House of Representatives’ Committee on Energy and Commerce 1998-2000. Mr. Manthei is recognized as a top FDA attorney in industry publications including Chambers USA (2010-2019) and as a Leading Lawyer by The Legal 500 US 2012-2019, a distinction shared with only thirteen individuals across all legal practice areas nationwide in his category. He was also named a Trailblazer by The National Law Journal (NLJ) in its annual report highlighting lawyers who have “achieved remarkable successes” in their field of work (2018). In addition, he has been recognized as one of five Life Sciences MVPs by Law360 (2016), repeatedly recognized as one of Washington’s Best Lawyers by Washingtonian magazine (2013), a Life Sciences Industry Star by Euromoney and LMG Life Sciences (2012 – 2018), one of the Top 40 Lawyers Under 40 by Washingtonian magazine (2006), and in Who’s Who in America, Who’s Who in American Law, Who’s Who International, and Who’s Who Legal: Lifesciences.Virtual Learning FAQ
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