SafeBiologics and GaBI invites you to their event

BIOSIMILAR RED TAPE ELIMINATION ACT (S2305): Weakening FDA Regulatory Standards for Biosimilars

About this event

BIOSIMILAR RED TAPE ELIMINATION ACT (S2305): Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health

Thursday, 31 October 2024 | 10:30 am – 11:30 am (EDT)

Online Event hosted by the ALLIANCE for SAFE BIOLOGIC MEDICINES in collaboration with GENERICS AND BIOSIMILARS INITIATIVE

This webinar on 'BIOSIMILAR RED TAPE ELIMINATION ACT (S2305)' aims to educate policymakers, healthcare providers, and patients on the current regulatory framework for biosimilars in the US, emphasizing the importance of maintaining the US FDA’s robust approval standards for interchangeable biosimilars, and highlighting the potential risks to patient safety and treatment efficacy that could arise from lowering those standards.

Speakers and programme line-up

Physician Perspective

Ralph McKibbin, MD, FACP, FACG, AGAF, Chair, Alliance for Safe Biologic Medicines, USA

Development of US State Biosimilar Substitution Policy

Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, College of Pharmacy, Ohio State University, USA

Regulatory Perspective on Biosimilar Red Tape Elimination Act

Michael S Reilly, Esq, Executive Director, Alliance for Safe Biologic Medicines, USA

Patient Perspective

Andrew Spiegel, Esq, Executive Director, Global Colon Cancer Association, USA

Panel discussion and Q&A with all speakers and participants

Find out more about the webinar, click here to download the agenda.

Don't miss out on this important and timely ASBM/GaBI event, REGISTER NOW!

For more information, email us at editorial@gabi-journal.net

If your schedule won't allow you to attend the live webinar, register anyway and watch on demand.

Hosted by

  • Guest speaker
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    Andrew Spiegel, Esq Executive Director @ Global Colon Cancer Association, USA

    Andrew Spiegel has over 20 years of experience in patient advocacy. He co-founded the Colon Cancer Alliance in the late 1990s, now a leading US-based advocacy group for colon cancer. As an attorney, he served as CEO for almost five years before founding the Global Colon Cancer Association (GCCA), an international patient advocacy organization representing colorectal cancer groups worldwide. Beyond colon cancer, Spiegel advocates for healthcare policies globally. He chaired the fundraising committee for the International Alliance of Patient Organizations and co-founded the World Patients Alliance, the world's largest patient organization. He is also involved with the Alliance for Safe Biologic Medicines and the Digestive Disease National Coalition. Spiegel holds a Bachelor's degree in Political Science with minors in English and Philosophy from Temple University, and a law degree from Widener University School of Law.

  • Guest speaker
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    Michael S Reilly, Esq Executive Director @ Alliance for Safe Biologic Medicines, USA

    Michael S Reilly is the executive director of Alliance for Safe Biologic Medicines since 2010. He has over a decade of experience in the federal government, focusing on healthcare policy. Previously, Mr Reilly served as the Associate Deputy Secretary at the US Department of Health and Human Services from 2005–2008, overseeing policy development and implementation, as well as regulatory matters concerning Centers for Medicare & Medicaid Services and the Food and Drug Administration (FDA). He was also a senior advisor to the assistant secretary for public affairs and the assistant secretary for planning and evaluation at HHS from 2002–2005. Throughout his career, Mr Reilly has contributed to FDA publications and co-authored numerous articles on biosimilars for the Generics and Biosimilars Initiative Journal. Also, he has been a speaker at various global health regulatory events, including the Australian Therapeutic Goods Administration, Health Canada and the World Health Organization.

  • Guest speaker
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    Ralph McKibbin, MD, FACP, FACG, AGAF Chair @ Alliance for Safe Biologic Medicines, USA

    Dr Ralph McKibbin is a practicing gastroenterologist at Blair Gastroenterology Associates in Altoona, PA. He is past president of both the Pennsylvania Society of Gastroenterology and of the Digestive Disease National Coalition (DDNC). He sits on the Member Advisory Panel of the Pennsylvania Medical Society; and is a member of the Pennsylvania State Cancer Control Consortium. Dr McKibbin has written extensively on the issues of non-medical switching and insurance industry utilization management techniques including step therapy and copay accumulator adjustments.

  • Guest speaker
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    Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP College of Pharmacy @ Ohio State University, USA

    Professor Philip Schneider has served as ASBM’s International Advisory Board chair since 2014. Schneider was Professor and Associate Dean for Academic and Professional Affairs for the University of Arizona, College of Pharmacy at the Phoenix Biomedical campus. In this position, he was responsible for the launch and growth of the College of Pharmacy program at the new Phoenix Biomedical Campus. He also held faculty appointments at the University of Arizona Colleges of Medicine and Public Health. He is a past president of the American Society of Health-System Pharmacists (ASHP) and past president of the American Society for Parenteral and Enteral Nutrition (ASPEN.), having served for 10 years as the first Editor-in-Chief of Nutrition in Clinical Practice, one of its two official publications. He is founder and principal of MediHealthInsight that provides consultation to the industry and others on matters related to improving the use of medicines.

  • Team member
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    SafeBiologics and GaBI 2024 Webinar Program Committee

SafeBiologics and GaBI

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The mission of GaBI is to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care.