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Substitution refers to dispensing one medicine instead of another equivalent/interchangeable medicine by the pharmacist without consulting the prescriber.

In some jurisdictions/countries, interchangeability and switching are only permitted or recommended in some patients/conditions and at different treatment periods (for example, initiating therapy versus continuation of therapy).³⁹ Switch comes with challenges, so there needs to be clear local and national biosimilar substitution and switching policies and switch management strategies are important.⁴⁰ Pharmacists should play a pivotal role in patient empowerment as well as raising awareness of biosimilars among physicians and patients and reducing scepticism about the safety of biosimilars.

Key challenges for the integration of biosimilars into routine biologic therapy include questions around interchangeability, switching, and automatic substitution. Additional switch studies and drug registries may enhance our understanding of the safety and effectiveness of switching and a key hurdle to broader adoption of biosimilars is lack of interchangeability with reference biologics.⁴¹

Chapter 7 deals with interchangeability principles and evidence.