Pharmacovigilance Considerations for Biosimilars in the USA

Area of Science:

• Pharmacovigilance
• Biotechnology
• Drug Safety

Background:

• The US anticipates multiple biosimilar approvals, necessitating robust postapproval safety monitoring.
• Biologic medicines are not identical, requiring vigilance for unique safety signals compared to reference products and other biosimilars.
• Current US safety monitoring relies on spontaneous reporting systems (SRSs) and active surveillance (AS).

Purpose of the Study:

• To describe existing US postapproval safety monitoring systems for biologics.
• To identify challenges in product identification and traceability within these systems.
• To provide recommendations for enhancing biologic safety surveillance.

Main Methods:

• Analysis of current spontaneous reporting systems (SRSs) and active surveillance (AS) mechanisms.
• Examination of product identification challenges in inpatient, ambulatory, and pharmacy settings.
• Review of existing and proposed regulatory frameworks, including the Drug Quality and Security Act.

Main Results:

• Accurate product identification is critical for both SRS and AS but is challenged by common nomenclature and coding for products from multiple manufacturers.
• Product traceability issues exist across diverse healthcare settings (inpatient, ambulatory, pharmacy).
• Current systems may not adequately address the unique needs of biosimilar safety monitoring.

Conclusions:

• Distinguishable nonproprietary names and codes for all biologics are recommended.
• Enhanced traceability measures, such as barcode utilization, are crucial for patient safety.
• Strengthening pharmacovigilance systems is vital for integrating biosimilars and maintaining patient confidence.