Clinical and Economic Value of a Biosimilar Portfolio to Stakeholders: A Conceptual Framework

OBJECTIVES: Stakeholders may derive unique value from manufacturers with biosimilar portfolios (vs. more limited offerings), especially when negotiating portfolio-based contracts or rebate programs. However, little is known about what types of value stakeholders may perceive from manufacturers with biosimilar portfolios outside of cost-savings. The objective of this study is to use the findings of a targeted literature review to develop a conceptual framework for the value of biosimilar portfolios to address this evidence gap.

METHODS: We conducted an integrative literature review in Embase and MEDLINE using the terms “biosimilar”, “portfolio”, and “biosimilar portfolio” to identify themes about the value of biosimilar portfolios to stakeholders. The search was limited to English language publications in the period of 1/1/2010-8/31/2023. Supplemental searches were conducted to identify studies broadly addressing “biosimilar process” and/or “biosimilar cost”, as well as sources addressing the value of product portfolios among non-pharmaceutical industry analogs. Results were used to develop a conceptual framework.

RESULTS: Literature searches identified no publications directly addressing biosimilar portfolio value, but supplemental searches identified the themes: 1) manufacturing complexity; 2) procurement, inventory, and storage; 3) administration; 4) education; and 5) transaction costs. Two non-pharmaceutical industry analog themes were also identified: product line length and single-supplier versus multiple-supplier procurement, as were two expert opinion themes: science credibility and research. Using these findings, we developed a conceptual framework that can be used to assess the value of biosimilar portfolios.

CONCLUSIONS: Our findings suggest that the concept of biosimilar portfolio value is multi-faceted and literature on this topic has been limited. To our knowledge, this is the first study to systematically assess and create a framework for biosimilar portfolio value from a pharmaceutical industry perspective. The conceptual framework can help to quantify the clinical and economic benefit of a biosimilar portfolio to stakeholders in future studies.