Defining a Framework for Sustainable Global Biosimilars Markets Using Findings from a Targeted Literature Review.

A biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing approved biologic referred to as "reference product." From the introduction of the first biosimilar in 2006 to today, a variety of challenges to biosimilar development and uptake have arisen across global markets, threatening sustainability. Consequences of an unsustainable market can include drug shortages, limited competition, and less innovation. However, there are few frameworks to facilitate systematic evaluation and action to address these threats. This study used a contemporary, targeted review of the global biosimilars literature to establish the key dimensions of biosimilar market sustainability. The most commonly referenced stakeholder groups were healthcare payers, government/legal/regulatory authorities, healthcare providers, biologic manufacturers, patients, and biologic purchasers. The most prevalent sustainability dimensions discussed were pricing and cost-savings, legal and regulatory barriers to market entry and access, manufacturer processes, provider choice in selecting biologic therapy, knowledge and preferences, and procurement processes. We incorporated these findings into a framework of biosimilar market sustainability dimensions that should be considered by stakeholders looking to ensure the long-term viability of the market.