Cardinal Health Biosimilar Report: $56 Billion in Savings and the Road to Market Sustainability

Since the first launch in 2015, biosimilars have fundamentally reshaped the US health care system, generating over $56 billion in savings, according to the 2026 Cardinal Health Biosimilars Report.1

Although biosimilars have generated billions in cumulative health care savings over the previous decade, new data suggest that achieving long-term market sustainability remained a complex objective. By early 2026, biosimilars accounted for approximately 23% of the total biologics market in the US. While the market demonstrated significant growth, stakeholders identified a "biosimilar void" that could result in $232 billion in missed savings over the next 10 years if current development and adoption trends do not accelerate.2

Regulatory and Pipeline Developments

The regulatory environment for biosimilars underwent a significant shift in late 2025. The FDA issued draft guidance that proposed the elimination of comparative efficacy studies (CES) for most biosimilar applications.3 This change was intended to streamline the approval process by focusing on analytical data rather than costly clinical trials. The FDA estimated that this shift could save manufacturers up to $100 million in development costs per product and reduce development timelines by as much as 50%.1

Looking forward, the pipeline for these therapies remains active. Nearly 25 new biosimilars are expected to receive FDA approval between 2026 and 2027, targeting therapeutic areas such as oncology, immunology, and retina. Despite this activity, a substantial gap persists; while more than 110 biologics are set to lose patent protection over the next decade, only 10% of those products have biosimilars currently in development.

Physician Perspectives and Adoption Drivers

A Cardinal Health survey of 101 physician practices in late 2025 revealed high levels of clinical confidence alongside persistent operational concerns. Approximately 99% of participating providers reported they felt confident explaining biosimilars to their patients. The survey indicated that adoption was primarily driven by clinical data (56%) and payer requirements (50%).

However, physicians also identified significant points of hesitancy. The leading concern, cited by 53% of respondents, involved the nonmedical switching of a long-term, stable patient from a reference biologic to a biosimilar. Reimbursement complexities were also noted as a barrier by 34% of the surveyed practices. Furthermore, 94% of respondents stated that a stable reimbursement rate for medical benefit biosimilars was an important factor in their utilization decisions.

The Adalimumab Case Study and the "Switchback" Phenomenon

The launch of adalimumab biosimilars provided a critical real-world test for market disruption. Although biosimilar adoption increased significantly, research from Truveta through April 2025 identified a notable "switchback" trend. Data showed that 13.2% of patients who initially transitioned to an adalimumab biosimilar eventually reverted to the reference biologic, Humira.

This phenomenon was particularly prevalent among older adults and patients with rheumatoid arthritis or ankylosing spondylitis. Notably, nearly 40% of these switchbacks occurred within the first 30 days of treatment. Experts attributed this trend largely to the nocebo effect—a psychological phenomenon where a patient's negative perceptions or anxiety regarding a new medication led to perceived worsened clinical outcomes or adverse events.

Specialty Trends: Oncology and Gastroenterology

The impact of biosimilars varied by specialty. Oncology remained the most mature market, achieving an average 81% market share within 5 years of initial competition. In contrast, community gastroenterology practices faced increasing operational complexity. These practices managed the simultaneous launch of 3 different biosimilar classes: infliximab, adalimumab, and ustekinumab.4 For these providers, the primary challenges included navigating frequently changing payer formularies and managing the logistics of a growing inventory of similar but nonidentical products.

The Path to Sustainability

The report concluded that the long-term viability of the biosimilar market depended on aligning stakeholder incentives and stabilizing reimbursement models. To address the projected "biosimilar void," the authors suggested that proactive policy measures were necessary to ensure that the health care system could realize the billions of dollars in potential savings offered by these therapies.

References

1. 2026 biosimilars report: driving access and patient outcomes in physician practices. Cardinal Health. February 24, 2026. Accessed February 24, 2026. https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/biosimilars-report.html
2. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars®. February 5, 2025. Accessed February 24, 2026. https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars
3. A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars. October 30, 2025. Accessed February 24, 2026. https://www.centerforbiosimilars.com/view/a-closer-look-at-new-fda-guidance-removing-barriers-to-biosimilar-development
4. Jeremias S. Adalimumab double take: the unexpected return to reference Humira. The Center for Biosimilars. June 30, 2025. Accessed February 24, 2026. https://www.centerforbiosimilars.com/view/adalimumab-double-take-the-unexpected-return-to-reference-humira