Episode 88 Biosimilars - Interchangeability & Switching 2023

This episode is a Step 5 - revisit to the table - as outlined in our 6 Step Patient-Led Problem Solving Process.

What do patients need to know about the upcoming changes to biosimilars and interchangeability in 2023? 

 

In this episode, Tiffany is joined by esteemed guest experts Michael Reilly, Dr. Ralph McKibbin and Andrew Spiegel to explore the difference between  interchangeability , automatic substitution, and non-medical switching. Gain valuable insights into how these differences impact patients not only in the USA but also on a global scale.

In addition, our guests discuss the latest proposed bills in the US regarding interchangeable biosimilars, offering expert perspectives on the legislative developments and their implications for patients and healthcare providers alike.

Join us on this episode as we explore the latest updates in interchangeable biosimilars and share ways to raise your voice against non-medical switching  of non-interchangeable biosimilars without physician involvement.

 

Episode Highlights : 

• What is the difference between Interchangeability, Automatic Substitution, and Non-Medical Switching?
• Latest proposed legislation regarding interchangeable biosimilars
• The importance of physician involvement in biosimilar substitution
• What is the chance of original biologic failure if you fail the biosimilar? (and other patient submitted questions)
• Updates on biosimilars advancements in the US and around the world 
• What are Automatic Substitution Laws?
• How patients can become involved in the fight against the new legislation proposed that would undermine the switching protections in state biosimilar substitution laws. 

 

Resources Mentioned In This Episode:

• AiArthritis Biosimilars Hotline: https://www.aiarthritis.org/biosimilars 
• EMA - What Is A Biosimilar : https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview
• Europe Interchangable: https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged 
• FDA Resources: https://www.youtube.com/watch?v=i0IJg511J5Q ; https://www.youtube.com/watch?v=ooP7djSgtBE 
• Video- Dr. McKibbin discusses survey findings and importance of interchangeability: https://youtu.be/R9ULgUQEcZ 
• Video: Dr. McKibbin presents a poster based on the 2021 US Physician Survey data https://youtu.be/mhL_EZsbSpE  also short and straightforward - the poster: https://safebiologics.org/wp-content/uploads/2022/07/DIA2022-Poster-FNL.pdf 
• ASBM Survey Findings: https://gabi-journal.net/us-prescribers-attitudes-and-perceptions-about-biosimilars.html  
• Link to All ASBM Surveys, including Australia, Canada, Europe, Latin America, US: https://safebiologics.org/surveys/ 

Meet Our Co-Hosts & Guests: 

• Tiffany is the CEO at International Foundation for AiArthritis and uses her professional expertise in mind-mapping and problem solving to help others, like her, who live with AiArthritis diseases work in unison to identify and solve unresolved community issues.

 

Connect with Tiffany:

• Facebook: @tiffanyAiArthritis
• Twitter: @TiffWRobertson
• LinkedIn: @TiffanyWestrichRobertson

 

• Ralph McKibbin, MD, FACP, FACG, AGAF  is the Chairman of Alliance for Safe Biologic Medicines. Dr. 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.
•  
• Andrew Spiegel has nearly two decades of experience in the patient advocacy arena. Spiegel co-founded the Colorectal Cancer Alliance and was longtime board member of the Alliance became CEO in January of 2008 and ran the CCA for nearly 5 years, before undertaking his next venture, the Global Colon Cancer Association (GCCA).In addition to his work in the colon cancer community, Spiegel is an active advocate for health care policies both in the US and now worldwide. He is a co-founder and currently serves on the steering committee of the Alliance for Safe Biologic Medicines (ASBM). He is on the Board of Directors, and in December 2014 was elected to Chair, of the Digestive Disease National Coalition (DDNC),a founding member of the Coalition to Increase Clinical Trial Participation and in May of 2016 he began a three year term as a member of the Board of Directors of the International Alliance of Patient Organizations (IAPO) where he chaired the fundraising committee. Spiegel has won multiple awards for his work in patient advocacy.

 

• Michael Reilly, Executive Director of Alliance for Safe Biologic Medicines, has served as the executive director of ASBM since its inception in 2010. He has more than a decade of experience in the federal government developing and implementing healthcare policy. Mr. Reilly served as the associate deputy secretary at the U.S. Department of Health and Human Services (HHS) from 2005-2008 responsible for policy development and implementation, as well as regulatory oversight for issues involving CMS and the FDA. In addition to serving as the associate deputy secretary, Mr. Reilly served as a senior advisor to the assistant secretary for public affairs and the assistant secretary for planning and evaluation at HHS from 2002-2005. Mr. Reilly has been quoted in a series of FDA publications and co-authored many articles on biosimilars for the Generics and Biosimilars Initiative Journal. He has also presented to health regulators worldwide, including the Australian TGA, Health Canada and the World Health Organization (WHO).

 

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AiArthritis Voices 360 is produced by the International Foundation for Autoimmune and Autoinflammatory Arthritis. Visit us on the web at www.aiarthritis.org/talkshow. Find us on Twitter, Instagram, TikTok, or Facebook (@IFAiArthritis) or email us (podcast@aiarthritis.org).  Be sure to check out our top-rated show on Feedspot!