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. 2021 Mar 21;38(5):2077–2093. doi: 10.1007/s12325-021-01688-9
Definitions regarding the interchangeability of a biosimilar for its innovator biologic vary across jurisdictions, with some (e.g., the European Union) requiring the input of the prescriber and others (e.g., the USA) permitting automatic substitution at the pharmacy-level independent of physician direction
Given potential issues with treatment persistence, pharmacovigilance, traceability, and manufacturing changes over time, additional data and guidance are needed to clarify the extent to which biosimilars should be considered interchangeable (if at all) and for how long
Like many professional medical societies and patient advocacy groups, we believe that treatment decisions should remain under the purview of physicians in consultation with their patients