Biosimilar Denosumab Could Reshape Access, Costs in Osteoporosis Care: Edward Li, PharmD

As biosimilar competition expands into osteoporosis care, the potential economic value of lower-cost treatment options is becoming an increasingly important consideration for payers and providers.

A recent cost-effectiveness analysis found that biosimilar denosumab could be a cost-effective alternative to bisphosphonates for postmenopausal osteoporosis, although the findings were sensitive to the biosimilar's price.¹ The analysis also highlights the broader question of whether lower treatment costs could help address persistent gaps in osteoporosis care. Edward Li, PharmD, corresponding author and head of health economics and outcomes research at Sandoz, discussed the potential value of biosimilar denosumab in an interview with the Center for Biosimilars^® (CFB).

In this Q&A, he discusses how biosimilar pricing could influence cost-effectiveness, the payer and provider factors that may shape adoption, and whether lower-cost denosumab could help address persistent gaps in osteoporosis treatment and access.

Sandoz's Edward Li explains how biosimilar denosumab pricing could reshape cost-effectiveness, payer access, and gaps in osteoporosis care. | Image credit: LinkedIn

This transcript was lightly edited for clarity.

CFB: Your model found that biosimilar denosumab was likely to be cost-effective at a willingness-to-pay threshold of $150,000 per quality-adjusted life year, but the results were highly sensitive to biosimilar price. What does this tell us about how pricing will ultimately determine the real-world value and accessibility of biosimilar denosumab?

Li: Historically, expensive biologic therapies have been heavily scrutinized by payers, and access is often restricted through prior authorization or requirements to try lower-cost alternatives first. Biosimilar competition creates a unique situation because the clinical value of the biologic is already established, and the major variable that changes is price.

As competition drives down costs, the value proposition improves, and that's exactly why cost-effectiveness assessments should be revisited after biosimilar entry. When access restrictions are based, at least in part, on the relative value of competing treatment options, those assumptions should be reevaluated as pricing changes.

The question is no longer whether the biologic works but whether the economic rationale for limiting access remains the same once biosimilar competition enters the market. Ultimately, payers will decide whether lower costs warrant broader access, but those decisions should be informed by an updated understanding of the therapy's value in the current marketplace.

CFB: The analysis assumes biosimilar denosumab has equivalent efficacy to reference denosumab while offering a lower cost. As biosimilar denosumab enters the US market, what factors beyond the drug's acquisition price—such as reimbursement, prescribing patterns, or payer policies—will be most important in translating that potential cost-effectiveness into greater patient access?

Li: Demonstrating that a biosimilar is cost-effective is an important first step, but it doesn't automatically translate into adoption. On the payer side, the key question is whether lower costs ultimately lead to changes in coverage policies and utilization management requirements.

Biosimilar competition can improve the value equation, but patients only benefit if that improved value is reflected in fewer access barriers and broader access to treatment. At the same time, osteoporosis remains significantly undertreated, with many patients who could benefit from therapy never receiving treatment at all. Even if cost barriers come down, there is still work to do to identify appropriate patients, initiate treatment, and keep them on therapy. Ultimately, improving patient access will require both payer and provider stakeholders to recognize how the value proposition has changed with biosimilar competition.

Improving patient access will require more than lower prices alone. There also needs to be ongoing dialogue with payers and providers about how biosimilar competition has changed the economics of treatment and what that means for coverage decisions and patient access.

CFB: About 70% of patients with osteoporosis in the US are estimated to go untreated, with adherence, adverse effects, and cost contributing to the gap. How could the availability of a lower-cost denosumab option change treatment decisions for patients who have struggled with oral bisphosphonates or have not received osteoporosis therapy?

Li: As biosimilar competition lowers the cost of denosumab, payers have an opportunity to reevaluate where it fits in the treatment pathway. If the cost differential continues to narrow, it raises an important question of whether bisphosphonates should remain the default treatment option for all patients. Greater access to effective therapies may help address a longstanding treatment gap in osteoporosis.

Beyond the direct impact on drug costs, payers should also consider the potential population-level benefits associated with preventing fractures and reducing the downstream consequences of untreated disease. If more patients are able to initiate and remain on effective therapy, the benefits could extend beyond individual patients to improvements in broader population health outcomes. In that sense, the value of biosimilar competition may extend well beyond the pharmacy budget.

Reference

1. Jeremias S. Biosimilar denosumab shows cost-effectiveness over bisphosphonates in PMO. The Center for Biosimilars. August 4, 2026. Accessed August 26, 2026. https://www.centerforbiosimilars.com/view/biosimilar-denosumab-shows-cost-effectiveness-over-bisphosphonates-in-pmo