
Biosimilar Entry Should Trigger a Fresh Look at Biologic Access
Experts at AMCP Nexus say biosimilar launches should prompt payers to revisit step therapy and measure value beyond market share.
Biosimilars have lowered prices and gained market share among US commercial plans, but experts at the
Lockhart was joined by Brian O’Rourke, BScPharm, PharmD, OMM, an independent health care advisor and former president and CEO, Canadian Agency for Drugs and Technologies in Health; James Chambers, PhD, MPharm, MSc, professor of medicine, Tufts University School of Medicine and investigator, Center for the evaluation of Value and Risk in Health at Tufts Medical Center; and Matt Mitchell, PharmD, MBA, MHP, FAMCP, chief pharmacy officer, Select Health/Scripius.
Lessons From Canada and Europe
O’Rourke said that biosimilars are now routine in Canada. His agency was once asked to run a full health technology assessment (HTA) on every new
About 90% of dispensed biologics in British Columbia, the first Canadian province to adopt mandatory switching, are biosimilars, O’Rourke said.2 Manitoba was the last province to do so in 2024. Overall, the provinces allow for a 6-month transition. “This gives the opportunity for the clinicians to have good conversations with their patients,” he explained.
In Europe, biologics have grown from 28% of pharmaceutical spending in 2014 to more than 40% in 2026, and biosimilars have generated an estimated €75 billion in cumulative
O’Rourke also described a September 2026 report from the Office of Health Economics, which concluded that price reductions from biosimilar entry enable broader access. The report recommended that entry could trigger a structured reassessment of the reference biologic to determine whether the new price justifies expanded access, additional indications, and earlier lines of therapy. The full value of biosimilars in the US remains largely unrealized, he said, even as many biologics are set to lost exclusivity over the next 5 years, with few biosimilars in development.4
US Progress and a Step Therapy Gap
Chambers, who developed the Tufts SPEC database tracking coverage
The US has been slower than Europe, Chambers said, in part because of the structure of its health system. “We have this fragmented system that creates uneven incentives across payers, providers, and also patients,” he said.
He then turned to ulcerative colitis (UC). The 2025 American College of Gastroenterology guideline notes that prior failure of conventional therapy is not always required before biologics. Yet across 215 UC coverage policies from the 17 largest commercial
In an interview with The American Journal of Managed Care®, Chambers said he hopes a biosimilar launch will lead to more than a new contract. “I think whenever a biologic loses exclusivity, hopefully in the future it won’t just trigger a contracting event, but [that] it will trigger a broader reassessment of the evidence, including what the guidelines are telling us to do,” he said. For now, he added, “This repositioning is nascent; it’s new, and I think that’s where hopefully we see changes and where biosimilars really begin to benefit patients in the future.”
Measuring Value Beyond Market Share
Mitchell offered a payer’s operating view. He cited net savings per member per month (PMPM) after adalimumab biosimilar implementation: $4.35 in Medicaid, $1.50 in Medicare, and $6.10 in commercial plans. After an ustekinumab implementation on July 1, 2025, across Medicaid, Medicare, and commercial plans, savings were $2.00, $2.50, and $4.80 PMPM, respectively, according to Samsung Bioepsis Biosimilar Marketing Report and Scripius data he presented.
But savings are only the start. “The challenge is often market structure, not the molecule,” he explained. He urged payers to define success beyond market share. “In my mind, we should be looking at sustained value, not just market share of an individual product.”
He outlines measures that included access (through first-line status), affordability (whether biosimilars can compete with branded co-pay assistance), continuity, and simplicity for members and providers. He also advised tracking patient migration rather than product conversion.
“If we’re looking at the migration, we’re following the patient, which in my mind is a little bit more important,” he noted. This means asking whether patients stay on therapy and, if not, where they go. Like Chambers, Mitchell said a biosimilar launch should prompt more than a new contract. It is “more than just a contracting opportunity. It’s the opportunity for us to go back and reassess,” he said, by revisiting the evidence, the economics, access, and operations before making a decision. In his view, the formulary decision is the midpoint, and
Patients, Prescribers, and Questions
During the question-and-answer period, Lockhart raised the patient perspective, citing an analysis in which “there was a patient who said they declined taking a new job” over concerns about insurance coverage and treatment continuity. Chambers said education and communication matter and that provider attitudes toward biosimilars have improved. Mitchell said aligning incentives and knowledge among providers and members may be a bigger opportunity than mandatory steps, although whether plans can broaden access without them remained an open question. Taken together, the speakers framed biosimilar entry as a chance to move from a product decision to a review of all of the treatment pathways.
References
- Lockhart C, Chambers JD, Mitchell M, O’Rourke B. Repositioning of biosimilars: how can the U.S. optimize biosimilar utilization to improve patient health and lower total cost of care. Presented at: AMCP Nexus 2026; October 26-29, 2026; San Diego, CA.
- Biologics in Canada. Part 1: market trends, 2018. Government of Canada. Updated May 12, 2020. Accessed October 28, 2026.
https://www.canada.ca/en/patented-medicine-prices-review/services/reports-studies/biologics-part1-market-trends.html - Biosimilar sustainability scorecards for Europe 2026. IQVIA. May 7, 2026. Accessed October 28, 2026.
https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilar-sustainability-scorecards-for-europe-2026 - Berdud M, Oyalo P, Tungate L, Garrison L, Cole A. Unlocking the broader value of biologic therapies through biosimilar-enabled access and repositioning. Office of Health Economics. Accessed October 28, 2026.
https://www.ohe.org/publications/unlocking-the-broader-value-of-biologic-therapies-through-biosimilar-enabled-access-and-repositioning/ - SPEC database. Center for the Evaluation of Value and Risk in Health. Accessed October 28, 2026.
https://cevr.tuftsmedicalcenter.org/databases/spec-database - Benfield MT, LaMountain F, Wong W, Kim E, Chambers JD. US commercial plans increase choice of biosimilar and originator products; market net prices decrease. Health Aff (Millwood). 2024;43(9):1290-1295. doi:10.1377/hlthaff.2023.01532
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