Biosimilars Drive Savings and Access, Yet Looming Development Gap Threatens Future

Biosimilars generated $20.2 billion in savings in 2024 alone, contributing to a total of $56.2 billion in savings since the first biosimilar entered the US market, according to a recent report by the Association for Accessible Medicines (AAM).¹

Biosimilars and generics drive significant health care savings, yet a concerning lack of biosimilar development for biologics set to lose exclusivity in the next 10 years threatens future access and affordability.| Image credit: Suriya - stock.adobe.com

The analysis titled the "U.S. Generic & Biosimilar Medicines Savings Report" also indicated that generic and biosimilar medicines collectively saved the US health care system a remarkable $467 billion in 2024, contributing to a total of nearly $3.4 trillion in savings over the preceding decade.

The report provided a special focus on the biosimilars market, celebrating a decade of progress since the first FDA approval. As of July 2025, the FDA had approved 84 biosimilars for 21 reference products, with 67 of these medicines now available to people. The increased affordability of biologic drugs due to biosimilar competition had also led to increased patient access, with people receiving an estimated 460 million more days of therapy than they would have without a biosimilar option. A recent analysis found that a second-to-market biosimilar entering within 3 years of the first could nearly double the pressure on average sales prices, accelerating price erosion for all treatments.

Despite these successes, a "biosimilar void" was identified as a significant concern.² The report explained that while 118 biologics were expected to lose patent exclusivity over the next decade, only 12 molecules currently had biosimilars in development. This meant that 90% of the biologics losing exclusivity in the coming years lacked a biosimilar in the pipeline, representing a potential $234 billion opportunity that was not being pursued. This was a stark contrast to the European Union, where a 2023 analysis found that 73% of high-sales biologics had a biosimilar in the pipeline, compared to only 23% in the US at the time.¹

The report attributed the slow adoption of biosimilars to a complex web of systemic barriers, including issues with pricing, reimbursement, and patent challenges. For instance, it was noted that while 25 first-to-market biosimilars were designated as interchangeable, adoption was still slower than anticipated due to reference biologic rebate barriers.

“Closing the biosimilar void in the U.S. will take more than incremental change. It requires coordinated action across an entire ecosystem of stakeholders – manufacturers, providers, payers, and policymakers – to confront perverse, profit-driven incentives, normalize swift biosimilar adoption, and establish clear, predictable pathways to robust biosimilar competition,” wrote Giuseppe Randazzo, interim executive director of AAM’s Biosimilars Council. "I urge policymakers to wake up! Biosimilars have already provided more life-saving treatments to more patients, but additional savings and access are possible. This future is within reach if we take the bold steps needed to fill the biosimilar void."

The report also mentioned that the Inflation Reduction Act (IRA) was instituting a price control process for brand drugs before generic and biosimilar competition had a chance to begin, potentially preempting the proven savings that competition could provide. A specific example was the biologic drug Stelara (reference ustekinumab), which was selected for negotiation under the IRA, but months later, a biosimilar version launched with a price more than 80% less than the brand. As of July 2025, 9 biosimilar products were on the market for Stelara, with prices as much as 90% less than the original list price. This case was presented as an example of how competition could achieve greater price reductions than government negotiation.

A Look at Generics

The report detailed that generics comprised roughly 90% of all prescriptions filled in the US in 2024, yet accounted for only 12% of total prescription drug spending. This disparity underscored the role of generics in providing cost-effective care. It was noted that since 2019, the amount spent on all generic sales in the US had decreased by $6.4 billion, even as the volume of prescriptions increased and new generic products were launched.

For example, the number of generic oral solids prescribed increased from approximately 167 billion in 2015 to around 197 billion in 2024, a 15% increase. Additionally, the average out-of-pocket cost for a generic prescription was $6.95 in 2024, a stark contrast to the nearly 5 times higher average of $28.69 for a brand-name drug. For people who were uninsured, brand-name drug costs increased by about 50% to $130.18 per prescription since 2019, while generic costs dropped by approximately $2.45, or 6%, during the same period.

While the generics market demonstrated consistent savings, the report also pointed to a concerning trend of price deflation. The analysis found that generic prices were launching and bottoming out at lower rates compared to 3 decades ago. Around 30 years ago, generic prices tended to stabilize at approximately 34% of the brand product's list price, but in the last decade, that percentage continued to fall to 22%. The report suggested this deflation could lead to unsustainable market conditions for generic manufacturers and potentially impact patient access.

The report also detailed that the Generic Drug User Fee Program (GDUFA), created in 2012, had a goal of accelerating the review and approval of generic applications. Prior to the program, the FDA had a backlog of more than 2,500 generic drug applications, with review times averaging 31 months. As a result of GDUFA, from 2017 to 2021, the FDA approved more than 3000 generic drugs, which helped ensure quicker patient access to these medications. However, the report concluded that additional actions from stakeholders, including manufacturers, providers, payers, and policymakers, were needed to normalize biosimilar adoption and establish predictable pathways for competition in order to fully realize the potential of these medicines.

John Murphy III, president and CEO of AAM, summarized in his introductory letter, “While the U.S. generic market is clearly in peril, solutions are not far out of reach. Policymakers must streamline FDA processes, curb patent abuse, stop [pharmacy benefit managers] and Medicare policies from denying patient access, and rollback harmful federal policies – including IRA price controls. The time to act in the best interest of America’s patients is now!”

References

1. 2025 U.S. generic & biosimilar medicines savings report. September 3, 2025. Accessed September 22, 2025. https://accessiblemeds.org/resources/reports/2025-savings-report/

2. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars^®. February 5, 2025. Accessed September 22, 2025. https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars