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Real‐world evidence (RWE) refers to data on the use of a drug product obtained outside of clinical trials.⁷⁷ In other words, the efficacy and safety data collected from medical records, pharmacovigilance records, personal devices, or electronic health applications after the medicine has been marketed, i.e. data and evidence about the drug product that is gathered during its widespread clinical use.

Depending on their design, RWE studies may follow patients for several years, or study treatments in patients not included in clinical trials (e.g. in children, elderly patients, or patients with concomitant diseases) or in clinical indications not studied during clinical trials. RWE studies may enhance the broader adoption of biosimilars.⁷⁸ Importantly, RWE studies must be carefully designed to yield credible, reproducible results using sound pharmaco‐epidemiological principles and practices.