BioDrugs (09/29/2015) Grampp, G.; Felix, T.

This year could see the approval of several biosimilars in the United States. Post-approval safety monitoring will be essential, however, as no two biologic medicines are identical. This monitoring could detect safety differences between a biosimilar, its reference product, and other biosimilars. In the United States, post-approval monitoring uses both spontaneous reporting systems and active surveillance systems. Both systems require accurate identification of the specific product administered to patients, but that information could potentially be compromised when products from multiple manufacturers share a common drug name or code. Amgen researchers in this article describe the systems, identify challenges and opportunities for product-specific safety surveillance of biologics in pharmacy and medical settings, and provide recommendations to increase biologic safety surveillance. They note that greater use of biosimilars will require distinguishable nonproprietary names and codes for all biologics as well as other methods of improving traceability.

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