CADTH has completed an environmental scan on Subsequent Entry Biologics (SEB) to support SEB related health care decision-making and policy development in Canada. The report, titled Subsequent Entry Biologics – Emerging Trends in Regulatory Health Technology Assessment Framework, aimed to address three topics concerning SEBs including regulatory trends in key markets, the biopharmaceutical industry pipelines and health technology assessment and reimbursement frameworks for SEBs internationally.
With respect to regulatory approval processes, scientific principles underlying guidelines for SEBs were shared among the UK, US and European Union regulatory authorities, including the importance of demonstrating similarity with the reference product. The type and magnitude of clinical data requirements vary among the authorities, but generally the clinical evidence required is less than for the reference products. The EMA was suggested as having been the global leader in issuing overarching guidelines on SEBs. Processes surrounding indication extrapolation are considered on a case-by-case basis.
Recent and upcoming patent expiries for top-selling biologics create opportunities for SEB development. According to the scan, numerous SEBs are currently in biopharmaceutical manufacturer pipelines, many of which are monoclonal antibodies. SEBs are predicted to have a substantial impact on biologic sales, spending and cost-savings.
Regarding HTA and reimbursement, most HTA agencies examined take different approaches to the evaluation of SEBs, however most assessments have acknowledged the comparable safety and efficacy of SEBs to their reference products. Differences in the agencies’ requirements, particularly with respect to the depth and necessity of economic evaluations for SEBs, were apparent from the scan.