Risk-Stratified Pharmacovigilance for Biosimilars in Saudi Arabia

Abstract

Risk-stratified pharmacovigilance offers an efficient approach for the surveillance of biosimilars. It leverages available sources of data and minimizes the need for extensive additional post-marketing data collection. Saudi Arabia’s biosimilar market has expanded in recent years, particularly for the treatment of autoimmune diseases and cancer. Nevertheless, although the country possesses an active pharmacovigilance system, further effort is necessary to establish a risk-stratified pharmacovigilance programme exclusively for biosimilars. (Omair et al.2022) Risk assessment generally relies on data available through clinical trials, regulatory submission processes, or post-marketing surveillance (Bin Yousef et al., 2022). Recruitment of the relevant stakeholders – including manufacturers, regulators, healthcare professionals, and patients – is crucial, as is maintenance of the trust of the public in the pharmacovigilance infrastructure (Alharf et al., 2018). The collected data facilitate the prioritization of where the most effort should be channeled, and serve to concentrate the limited resources available on the most problematic biosimilars. In Saudi Arabia—currently exhibiting a rapidly growing biopharmaceutical industry—, is undertaking regulatory and institutional changes to effectively respond to the imminent biosimilar market.  This presented article explores those factors and formulates a framework for a risk-stratified pharmacovigilance strategy. The proposal starts by conducting a preliminary review of the literature, followed by the establishment of a risk-assessment methodology; subsequently, data sources relevant to pharmacovigilance are characterized, and specific challenges of biosimilars in the Saudi Arabian context are discussed. A general overview of risk-stratified approaches follows, with a particular emphasis on the benefits of incorporating advanced analytic tools that augment traditional systems.