A key clinical consideration is how and when biologics, including biosimilars, can be safely used. A clinician may choose to transition or switch the biologic medicine a patient is currently treated with for another biologic—either a different brand or a biosimilar—that is approved and available to treat the same condition. This is a decision made by a healthcare provider in consultation with the patient.1
Automatic substitution (or pharmacy substitution) is a practice where a pharmacist may dispense an alternative medicine for a prescribed medicine without the prior approval of the prescribing healthcare provider. In the US, this is appropriate only for biosimilars that are designated by the FDA as “interchangeable” and where permitted under state law. In the EU, automatic substitution of biosimilars by pharmacists is not routinely practiced, and most nations have introduced laws or guidelines against it.1-4
An important consideration for biosimilars is that they have distinguishable names so that healthcare professionals and patients clearly understand which medicine is being administered. It is also important that the prescribing physician is given clear labels describing their safety and the data behind the approval decision so that an informed choice can be made regarding the appropriate medicine for the patient.5,6
Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists
References: 1. Canadian Agency for Drugs and Technologies in Health. Biosimilar drugs. www.cadth.ca/sites/default/files/pdf/biosimilar_drugs_professional_en.pdf. Accessed October 29, 2019. 2. US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product. www.fda.gov.downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm537135.pdf. Accessed October 29, 2019. 3. Generics and Biosimilars Initiative. Interchangeability of biosimilars around the world. www.gabionline.net/Reports/Interchangeability-of-biosimilars-around-the-world. Accessed October 29, 2019. 4. Generics and Biosimilars Initiative. Biosimilar substitution in Europe. www.gabionline.net/Reports/Biosimilar-substitution-in-Europe. Accessed October 29, 2019. 5. Regulatory Affairs Professionals Society. Regulatory explainer: everything you need to know about biosimilars. www.raps.org/Regulatory-Focus/News/2016/08/10/25569/Regulatory-Explainer-Everything-You-Need-to-Know-About-Biosimilars/. Accessed October 29, 2019. 6. European Commission. What you need to know about biosimilar medicinal products: a consensus information paper. www.ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf. Accessed October 29, 2019.