Biosimilars are now key players in the global drugs market offering potentially more affordable treatment options with similar safety and efficacy. However, there are concerns about non-medical switching practices of originator biologicals/biosimilars in different regions. A webinar was held on 20 July 2022 to discuss non-medical switching practices and to explore the importance of safeguarding the physician–patient relationship [1].
The webinar was jointly hosted by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI).
The webinar was moderated by Dr Steven Stranne, JD, and partner at Foley Hoag LLP, who has a unique perspective as a physician and lawyer.
Experts from various countries shared valuable insights in the webinar [2]. Mr Michael S Reilly, Executive Director of the ASBM, provided an overview of the policies in Europe and the US, shedding light on their implications. Ms Gail Attara, President and CEO of the Gastrointestinal Society in Canada, discussed the current state of non-medical switching policies in her country. Dr Ralph D McKibbin, a respected physician/gastroenterologist, shared US physicians' concerns and experiences with non-medical switching of biologicals/biosimilars. Dr Leah Christl, Executive Director at Amgen, presented the US perspective on the interchangeability of biologicals/biosimilars. Dr Durhane Wong-Rieger, President and CEO of the Canadian Organization for Rare Disorders, provided the patients' perspective and expectations regarding non-medical switching. Professor Philip J Schneider, from the Ohio State University College of Pharmacy, discussed the implications of Canadian non-medical switching policies on biologicals/biosimilars for physicians and patients. The presentations were complemented by the insights of Ms Jaymee Maaghop, Outreach Coordinator at the Gastrointestinal Society, Canada, and Ms Urvashi Rathod, Project Officer at the International Federation on Ageing, Canada, who served as panelists, further enriching the discussion.
Overall, the panel was made up of academic, clinician, patient advocates, industry specialist, policymakers and regulatory experts from Canada and the US. The contributors discussed non-medical switching practices of biologicals, including biosimilars, in Canada, the US and Europe and explored the importance of safeguarding the physician–patient relationship. The discussion that followed the presentations highlighted that improved information and protecting the physician–patient relationship in medical switching will encourage smooth uptake of biosimilars.
The webinar provided the opportunity to gain insight on ‘switching and substitution practices’ in Canada and Europe and the interchangeable designation in the US. The speakers shared their experience and knowledge on switching and substitution practices globally and principles on interchangeability of biosimilars in the US. There was specific emphasis on the forced-switching policies adopted in Canada and their shortcomings. The regulatory and scientific standards for interchangeable biosimilars in the US were generally supported. The importance of a multi-stakeholder approach protecting the physician–patient relationship in the practice of switching of biologicals, including biosimilars, was brought to the fore.
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Reference
1. Reilly MS, Attara G, McKibbin RD, Schneider PJ. Non-medical switching of biologicals/biosimilars: Canada, Europe and the US – a webinar report. Generics and Biosimilars Initiative Journal (GaBI Journal). 2022;11(3):96-102. doi:
10.5639/gabij.2023.1201.006
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