Abstract
BACKGROUND AND OBJECTIVE: Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by stakeholders, there are numerous barriers to the uptake of biosimilars. To realise the promise of biosimilars reducing costs, barriers must be identified, understood, and overcome, and enablers magnified. The aim of this systematic review is to summarise the enablers and barriers affecting uptake of biosimilars through the application of a classification system to organise them into healthcare professional (HCP), patient, or systemic categories. METHODS: A systematic literature search was performed in PubMed, Scopus, CINAHL, eConlit, and Embase. Included were primary research studies published in English between Jan 2017 through June 2023 focused on enablers and barriers affecting uptake of biosimilars. Excluded studies comprised comparisons of biosimilar efficacy and safety versus the reference biologic. One reviewer extracted data that included classification of barriers or enablers, the sub-classification, and the identification of the degree of agency associated with the actor through their role and associations as a mediator within their network, through the application of Actor Network Theory. The data were validated by a second reviewer (PV). RESULTS: Of the 94 studies included, 59 were cross-sectional, 20 were qualitative research, 12 were cohort studies, and three were economic evaluations. Within the review, 51 of the studies included HCP populations and 35 included patients. Policies and guidelines were the most cited group of enablers, overall. Systemic enablers were addressed in 29 studies. For patients, the most frequently cited enabler was positive framing of a biosimilar, while for HCPs, cost benefit was the most frequently noted enabler. The most frequently discussed systemic barrier to biosimilar acceptance was lack of effective policies or guidelines, followed by lack of financial incentives, while the most significant barriers for HCPs and patients, respectively, were their lack of general knowledge about biosimilars and concerns about safety and efficacy. Systemic actors and HCPs most frequently acted with broad degree of agency as mediators, while patient most frequently acted with a narrow degree of agency as mediators within their networks. CONCLUSIONS: Barriers and enablers affecting uptake of biosimilars are interconnected within networks, and can be divided into systemic, HCP, and patient categories. Understanding the agency of actors within networks may allow for more comprehensive and effective approaches. Systemic enablers in the form of policies appear to be the most effective overall levers in affecting uptake of biosimilars, with policy makers advised to give careful consideration to appropriately educating HCPs and positively framing biosimilars for patients.