Review Finds 7 Themes That Can Help Define the Value of Biosimilars

Researchers developed a framework featuring 7 pillars that can help stakeholders determine the true value of a biosimilar portfolio. The framework was based on findings from an integrated literature review published in ClinicoEconomics and Outcomes Research.

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Portfolios, used across industries to mitigate risk and spur innovation, have recently been adopted by the pharmaceutical sector, traditionally focused on single products. This model reduces investment risk and offers financial incentives across multiple assets but can lead to resource scarcity and decision-making complexities. Pharmacoeconomic evaluations often focus on cost but overlook other values like reducing uncertainty and fostering hope.

Because of this, biosimilars are primarily developed by smaller companies or spinoff companies (eg, Sandoz vs Novartis, Samsung Bioepis vs Samsung Biologics). Stakeholders consider clinical efficacy, safety, and economic evidence, yet the value of a biosimilar portfolio, particularly in rebate programs, is not well understood. The review aimed to develop a framework to provide clarity on the value of a biosimilar portfolio, which was defined as 3 or more biosimilars from a single manufacturer.

The researchers searched databases for studies published in English between 2010 and May 2022. For inclusion, the studies had to be observational studies, systematic literature reviews, non-systematic review, or narrative reviews that reported on the value of a biosimilar portfolio in decision-making by stakeholders.

Of the original 1577 records identified, 15 studies were included in the analysis. Although none of the studies investigated biosimilar portfolio value, the researchers noted common themes among the analyses that could help define portfolio value:

• Manufacturing
• Procurement
• Inventory
• Storage
• Administration
• Education
• Transaction costs

Manufacturing biosimilars is complex, involving multiple purification and production stages, with small process changes potentially impacting their structure and function. Drug shortages are also common, so clinicians and pharmacy staff may prefer biosimilars from reliable manufacturers with a positive history regarding recalls, safe handling, and supply chain security.

In terms of procurement, inventory, and storage, managing multiple products can be challenging and costly, especially if the wrong biosimilar brand is administered and not reimbursed by health plans. For administration, preferences may develop for different delivery methods and timing, which can impact the clinical and economic value for patients, pharmacy staff, and institutions.

Education on biosimilars is resource-intensive, but a biosimilar portfolio can streamline this process by sharing educational materials across stakeholders, providing clinical and economic value. Transaction costs associated with switching biosimilars could be minimized with a portfolio from a single manufacturer, offering consistent reimbursement support while reducing resources needed for dealing with multiple manufacturers.

In the pharmaceutical industry, innovation and being first-to-launch can boost a company's market share and credibility. Larger companies are often seen as more credible due to their capabilities. The authors of the review outlined several benefits of having a biosimilar portfolio, including that these portfolios can provide steady funding for clinical trials, which benefits research institutions. Longer product lines, as seen in other industries, can also improve brand quality, suggesting that biosimilar portfolios may be more valued than single biosimilar products. Additionally, single-supplier procurement offers collaboration, trust, and lower management costs, making biosimilar portfolios economically beneficial.

The authors said it’s possible that their review missed relevant studies published before 2010 and after May 2022.

“The conceptual framework described here creates a basis for validating the elements through future research efforts…. It may be possible that new themes may emerge with a stakeholder survey and that some of the hypothetical themes may be deemed non-essential in describing biosimilar portfolio value. Additionally, it would be of interest to complete the survey across countries and regions given intrinsic differences in healthcare systems,” the authors suggested.

References

Fox GE, Bernauer M, Stephens JM, Jackson B, Roth JA, Shelbaya A. Clinical and economic value of a biosimilar portfolio to stakeholders: An integrative literature review. Clinicoecon Outcomes Res. 2024:16:247-256. doi: 10.2147/CEOR.S445697.