Non-medical switching of biologicals/biosimilars Canada, Europe and the US: a webinar report
Category: Meeting Report
116 total, 2 today
Keywords: biologicals, biosimilars, forced-switching, interchangeable biosimilar, non-medical switching
Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP
Introduction: 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 to discuss non-medical switching practices and to explore the importance of safeguarding the physician–patient relationship.
Methods: The webinar was held by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI) on 20 July 2022. It consisted of various expert speaker presentations followed by a Q&A with the panel. The audience also had the opportunity to ask questions online throughout the webinar.
Results: Presentations discussed key concerns about non-medical switching practices of originator biological/biosimilar medicines. There was particular emphasis on the practices in Canada, Europe, and the US. Further details of the presentations were discussed during the Q&A and clarifications were made via the concurrent online Q&A.
Conclusion: The webinar enabled in-depth discussion of non-medical switching practices in Canada, Europe, and the US. There was specific emphasis on the forced-switching policies adopted in Canada and their shortcomings. There was also discussion about the US’s interchangeability designation. Overall, it was highlighted that safeguarding the physician–patient relationship is key in decisions about biologicals prescribing, dispensing, and reimbursement. This can be achieved through robust policy and regulation and upholding transparent practices.
Submitted: 19 December 2022; Revised: 20 January 2023; Accepted: 21 January 2023; Published online first: 3 February 2023
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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.