OBJECTIVES: Biosimilars are biologic medications that are highly similar to, and have no clinically meaningful differences from, existing approved biologics known as “reference products”. Typically, biosimilars are priced below their reference products, creating an economic incentive for use to reduce expenses. However, a variety of challenges to biosimilar development and uptake have arisen across global markets and threaten their sustainability. The objective of this study was to conduct a targeted literature review of the biosimilars literature to identify key sustainability dimensions of this market to inform future research, stakeholder interactions, and policy initiatives aimed at ensuring the long-term viability of global biosimilars markets.

METHODS: We searched publications in PubMed and EMBASE for the period 1/2013 to 9/2023 to identify literature addressing aspects of biosimilar market sustainability using the terms ‘biosimilars’, ‘market sustainability’, ‘market access’, ‘pricing and reimbursement’, ‘market dynamics’, ‘market trends’, and ‘price erosion’. We also searched conference abstracts in those databases and relevant policy documents and white papers from 2019 onward. Among included publications, we identified the most prevalent biosimilar sustainability themes to define key dimensions of ‘sustainability’.

RESULTS: Among 788 relevant publications, 108 (13.7%) were included. The most commonly referenced sustainability dimensions were: pricing/cost-savings (n=102 studies), barriers to market entry/access (n=84), manufacturer processes (n=72), physician prescription choice (n=64), biosimilar knowledge and preferences (n=40), and biosimilar procurement processes (n=39). Key elements within each dimension were also summarized.

CONCLUSIONS: This study used a contemporary review of the global biosimilars literature to establish the key dimensions of biosimilar market sustainability that should be considered by stakeholders looking to ensure the long-term viability of the market. Our findings will be used to develop a framework to facilitate research, collaboration, and policy focused on optimizing the cost-saving potential of biosimilar therapies across global markets.