Evaluating the feasibility of health care databases for assessing the safety of switching between originator biologics and biosimilars

BACKGROUND: Real-world data (RWD) have received considerable attention recently, namely, with regard to their value in providing further evidence about the benefit-risk profile for medicinal products beyond clinical trial data. RWD may be particularly useful for establishing interchangeability and supporting switching decisions between originator biologics and their biosimilars. OBJECTIVE: To evaluate the fitness of 3 US health care databases-a national, commercial health plan, a regional integrated delivery network (IDN), and a multipayer, national claims-based database (henceforth, multipayer database)-for capturing data from clinical trials assessing interchangeability between originator biologics and biosimilars across multiple therapeutic areas. METHODS: We identified 8 clinical trials examining switching between originator biologics and biosimilars from the published literature and ClinicalTrials.gov. All variables representing inclusion/exclusion criteria, interventions, and outcomes from these trials were recorded and grouped into 8 categories: assessment, behavior, demographic, diagnostic, laboratory, procedure, treatment, and vital signs. The 3 databases were then individually evaluated based on the availability of variables identified from the clinical trials and by calculating the percentage of observed data in each database for all relevant variables across the clinical trials, overall and within the above categories. RESULTS: The population size varied across the databases (4 million for the regional IDN through 170 million patient-lives in the multipayer database). All databases had complete (100%) capture for procedure, treatment, and vital signs data and performed well for capturing diagnostic information (78%-100%). Most demographic information (eg, age, sex) was captured; however, race and ethnicity was not available for all databases. Seventy-one percent of the behavior data (eg, whether the patient was sexually active) was captured by the commercial health plan and the regional IDN, but only 29% by the multipayer database. Assessment data (eg, survival, functional status) varied across the databases, with the regional IDN having 93% data capture vs 37% and 16% in the commercial health plan and multipayer database, respectively. Notable differences among the databases were also observed for laboratory data; the regional IDN had complete capture vs only 6% in the multipayer database. CONCLUSIONS: Health care databases provide information such as diagnoses, treatments, and some outcomes that may be useful for generating real-world evidence relevant to biosimilar regulatory assessment. However, details on treatment effectiveness may be limited. Specific databases should be evaluated according to their unique attributes to select the most appropriate source(s) of information for a given research need. Further studies are warranted to evaluate data accuracy and timeliness in health care databases.