America’s healthcare system is at a crossroads. Over the last decade, biosimilars have delivered billions in savings for patients, employers, and taxpayers—offering lower-cost alternatives to expensive biologic medicines. But now, a dangerous trend threatens to halt this progress. A new analysis from the IQVIA Institute has revealed a massive biosimilar void: a staggering 90% of biologic drugs losing patent exclusivity over the next ten years have no biosimilar competition in the pipeline. If we don’t act now, millions of patients will be locked out of potential savings and forced to pay higher prices for essential medications.
Biosimilars: A Promise That Must Be Kept
Since the first biosimilar launched in 2015, these lower-cost medicines have saved the healthcare system nearly $36 billion. These savings were supposed to continue growing as more biosimilars entered the market. Instead, we’re seeing a slowdown in biosimilar development, an uneven playing field that discourages competition, and a policy, regulatory and reimbursement landscape that makes it harder—not easier—for biosimilars to gain traction.
The numbers speak for themselves. 118 biologics will lose patent protection between 2025 and 2034, representing a $234 billion market opportunity. But as of today, only 12 of these medicines have biosimilars in development. The rest? Stuck in the void. This isn’t just a missed opportunity—it’s a direct hit to patients who rely on these medicines.
For example, looking at Medicare patient populations:
- 860,000 patients with diabetes depend on biologics for treatment, yet biosimilar development in this space is virtually nonexistent.
- 102,000 neurology patients—including those with multiple sclerosis—face the same fate, with no biosimilars in sight.
- 160,000 immunology patients who could benefit from biosimilars are left waiting as brand-name monopolies remain intact.
And this does not begin to count the millions of patients in Medicare and the commercial market with conditions that require therapies in the hematology, ophthalmology, osteoporosis, and gastrointestinal areas, among others, who would benefit from lower cost biosimilar medicines.
Why Are Biosimilars Falling Behind?
Despite their proven value, biosimilars are facing barriers at every turn:
- Regulatory Burdens: The FDA’s approval process for biosimilars is still plagued by redundant and costly requirements, including unnecessary clinical efficacy studies and confusion about biosimilars vs interchangeable biologics. This slows down development and drives up costs, deterring investment in biosimilar pipelines.
- Patent Abuse: Brand-name drug manufacturers exploit patent thickets and legal loopholes to extend monopolies, keeping lower-cost alternatives off the market for years.
- Perverse Market Incentives: Even when biosimilars are approved, insurers and pharmacy benefit managers (PBMs) often favor higher-priced brand drugs over biosimilars, limiting uptake and undercutting competition.
- The Inflation Reduction Act’s Unintended Consequences: Instead of fostering biosimilar adoption, the IRA’s drug pricing policies have actually discouraged development by making it less financially viable for manufacturers to enter the market.
Policymakers Must Act—Now
We cannot afford to let biosimilars stagnate. Policymakers must take bold action to correct course and close the biosimilar void before it’s too late. Here’s what needs to happen:
- Eliminate Unnecessary Regulatory Barriers
- The FDA must remove outdated requirements, such as unnecessary clinical efficacy trials, and permit use of global comparators to streamline biosimilar development and bring new competition to market faster. And Congress should follow the FDA’s recommendation to remove the statutory distinction between biosimilars and interchangeable biologics.
- End Abusive Patent Thickets
- Congress must curb the abuse of the patent system, preventing brand manufacturers from using patent thickets to block competition indefinitely.
- Ensure Rapid Patient Access
- Medicare, PBMs and health plans should cover biosimilars at launch—no more favoring higher-priced drugs at the expense of patients—unless the brand-name drug has lowered its price and costs less at the unit level.Ensure Rapid Patient Access
- Reverse the Damage Done by the Inflation Reduction Act
- Congress must adjust drug pricing policies to ensure biosimilar competition is encouraged—not punished. The arbitrary and unpredictable nature of the IRA’s price control framework discourages new investments in biosimilars, the end result of which will be fewer and slower biosimilar competitors—and higher prices for America’s employers and patients.
The Cost of Inaction
If nothing changes, patients and the healthcare system will pay the price. A fully competitive biosimilar market could save the U.S. an additional $189 billion over the next decade—but those savings will vanish if biosimilars remain trapped in the void. This isn’t just a theoretical discussion—it’s a crisis that will impact real people: the diabetic patient struggling to afford their insulin, the cancer survivor burdened by high treatment costs, the retiree on a fixed income choosing between medicine and rent.
We have the tools to fix this. Now, policymakers need to use them. The future of biosimilar competition—and the health of millions of Americans—depends on it.