Developing Systems to Support Pharmacovigilance of Biologic Products

Biologic products show great promise as treatments for a variety of illnesses, including cancer and autoimmune diseases. However, the complexity of these products creates unique challenges for monitoring their safety in the postmarket setting. Specifically, variations between similar biologic products and batches of the same product may be associated with significant adverse events. As such, pharmacovigilance systems must be able to distinguish between products with a high level of specificity.

On November 15, the Engelberg Center for Health Care Reform convened an expert workshop, “Developing Systems to Support Pharmacovigilance of Biologic Products” to explore strategies that support the identification of products for safety surveillance and monitoring. Participating stakeholders included safety surveillance experts, the biologics industry, patient advocacy groups, clinicians, pharmacists, provider systems, payers, academia, and regulators. These stakeholders shared their input on pharmacovigilance issues associated with biologics, explored lessons from international regulatory experiences, and examined mechanisms to identify biologics to support safety surveillance.