P112: Assessing Feasibility of Using RWD to Support Biosimilar Development: Rituximab use in US Patients with Follicular Lymphoma

Poster Presenter

Jeanine Flanigan

HEOR specialist
Sandoz
United States

Objectives

Recently, ECAs have been used for regulatory approval of various new therapies, however, none have been for biosimilars; this case study assessed the feasibility of developing an external control arm (ECA) for a proposed US rituximab biosimilar for treatment of follicular lymphoma (FL).

Method

This retrospective feasibility study used electronic medical record (EMR) data from the ConcertAI Oncology Dataset. The sample included 150 real-world patients, diagnosed with FL from 01/13/2016 to 05/04/2022, who were selected through stratified random sampling using structured EMR data elements.

Results

The study sample was evaluated for various criteria, including diagnosis of FL, age, and rituximab use, based on manual patient chart review. With each criterion, the sample size was extrapolated using a bootstrapping method to reflect the estimated number of patients with 95% confidence intervals to the broader dataset. An estimated 2,089 patients (95% CI: 1944, 2183) with confirmed FL diagnosis were identified in the overall dataset, of whom, an estimated 1,606 (95% CI: 1367, 1838) patients received rituximab after FL diagnosis. Moreover, there was evidence of patients who met additional criteria relating to specific rituximab dose timing and frequency, FL tumor characteristics, and adverse event reporting.

Conclusion

In this case study, the human review feasibility demonstrated evidence of comparability between real-world patients and clinical trial patients after application of specific criteria. However, variable definitions may need to be adapted to reliably identify control patients with adequate data completeness using real-world data. Biosimilar sponsors may be able to utilize RWD for generating an ECA, which can be useful in future regulatory decision making.