In January 2025, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a position paper, ‘Pharmacy-mediated substitution for biosimilars’.
This position paper discusses the substitution of biosimilars for their reference products at retail pharmacies, without requiring prescriber approval. At time of writing, in the US this is possible if a biosimilar is designated ‘interchangeable’. In other jurisdictions, such as Europe, this is not generally an option [1].
The position paper is primarily aimed at pharmacists; however, the outlined principles also apply to regulators, healthcare providers, payers, and those involved in formulary decisions.
The core principles for pharmacy-mediated substitution, as outlined by the position paper are:
- Regulatory Oversight – A science-based framework should guide the regulatory approval of biosimilar substitution.
- Prescriber Authority – Physicians should retain the right to specify ‘do not substitute’ or ‘dispense as written’ on prescriptions.
- Safety in Switching – Substitution should only be permitted if data confirm that repeated switching between the reference biological and biosimilar does not increase risk. Exemptions may apply when:
- The product is not used chronically.
- The biosimilar is a less complex protein with low immunogenic risk.
- Indication-Specific Use – Substitution should be allowed only for approved indications, ensuring compliance with regulatory and intellectual property considerations.
- Device Compatibility – Patients must be able to safely use the biosimilar’s delivery device without additional medical supervision.
- Traceability – Robust tracking measures, including batch number documentation, are essential for pharmacovigilance and patient safety.
By adhering to these principles, the IFPMA note that pharmacy-mediated substitution can support patient safety, treatment efficacy, and regulatory compliance in the use of biosimilars.
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Reference
1. Reilly MS. Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(1):34-6. doi:10.5639/gabij.2024.1301.006
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