A key clinical consideration is how and when biologics and 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 health care provider in consultation with the patient.1
Substitution (sometimes referred to as automatic 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 physician. In the US, this is appropriate for biosimilars that are designated by the FDA as “interchangeable” and where permitted under state law. In Europe, automatic substitution of biosimilars by pharmacists is not routinely practiced, and most have introduced laws or guidelines against it.2
One of the most important considerations for biosimilars is that they have distinguishable names so that health care 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.1,3
References: 1. 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 December 21, 2018. 2. Generics and Biosimilars Initiative. Biosimilar Substitution in Europe. www.gabionline.net/Reports/Biosimilar-substitution-in-Europe. Accessed February 25, 2019. 3. 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 December 21, 2018.