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. 2015 Oct;29(5):309-21.
doi: 10.1007/s40259-015-0137-2.

Pharmacovigilance Considerations for Biosimilars in the USA

Free PMC article

Pharmacovigilance Considerations for Biosimilars in the USA

Gustavo Grampp et al. BioDrugs. .
Free PMC article


In 2015, five or more biosimilars may be approved in the USA. Because no two biologic medicines are identical, postapproval safety monitoring will be critical to detect potential differences in safety signals between a biosimilar, its reference product, and other biosimilars. Postapproval safety monitoring in the USA uses two signal detection systems: spontaneous reporting systems (SRSs) and active surveillance (AS) systems. Both depend on accurate identification of the specific product(s) dispensed or administered to patients, which may be compromised when products from multiple manufacturers share common drug nomenclature or coding. Product identification can present challenges across different healthcare settings, including inpatient and ambulatory care. Common oral-dosage drugs are predominantly dispensed directly to patients by pharmacists, whereas most injectable drugs, including biologics, are administered to patients by healthcare professionals in outpatient clinics or hospitals. Thus, the effectiveness of SRS and AS mechanisms in both pharmacy and medical channels must be given greater consideration as biotechnology matures. In this article, we describe these systems and their limitations. We identify challenges and opportunities for product-specific safety surveillance of biologics in both the pharmacy and medical settings and provide recommendations to improve biologic safety surveillance under the current and future systems envisioned in the Drug Quality and Security Act. As biosimilars are integrated into existing pharmacovigilance systems, distinguishable nonproprietary names and codes for all biologics, as well as other opportunities to improve traceability (e.g., increased use of barcodes), must be considered to ensure patient safety and confidence in this new class of drugs.


Fig. 1
Fig. 1
Schematic of prescription order entry and fulfillment at a US medical institution, demonstrating how reported adverse events (AEs) can be misattributed. When a generic supply of medication is introduced into the in-house pharmacy inventory, administrative staff may not introduce new identifier records specific to the generic. Instead, the generic may be identified in the prescription order entry and electronic health record (EHR) systems as if the originator product were being ordered and dispensed. 2D two-dimensional, FDA US Food and Drug Administration, USAN US Adopted Name
Fig. 2
Fig. 2
Four dimensions to consider for effective biologic pharmacovigilance. DSCSA Drug Supply Chain Security Act, EHR electronic health record, FDA US Food and Drug Administration, HCPCS Healthcare Common Procedure Coding System, NDC National Drug Code, Rx prescription

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