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The U.S. Food and Drug Administration (FDA) initiated this study to evaluate the feasibility of identifying complex generic products and conducting active surveillance of newly approved complex generics within the Sentinel System. Copaxone (glatiramer acetate) was chosen as a test case due to the availability of a product-specific guidance for demonstrating bioequivalence. Both Copaxone and Glatopa (the first generic form of glatiramer), are indicated for the treatment of relapsing forms of multiple sclerosis (MS).
This analysis specifically aimed to assess the utilization of brand and generic forms of glatiramer in MS patients. Results showed 145 patients exposed to Glatopa, 5422 patients exposed to Copaxone 20mg and 4813 patients exposed to Copaxone 40mg from September 21, 2010, to January 31, 2018. Due to low utilization of Glatopa, the FDA determined that Sentinel’s Active Risk Identification and Analysis (ARIA) system was insufficient for conducting an inferential analysis; product utilization could be re-evaluated in the future.
Additionally, this study explored five different algorithms for identifying MS relapse. Algorithms that included diagnoses in outpatient settings captured more MS relapses than algorithms that included diagnoses in inpatient settings alone.