John Murphy III, President and CEO of the Association for Accessible Medicines (AAM), argues that 2026 represents a pivotal moment for the United States to reclaim leadership in biosimilars. He outlines how recent FDA reforms could finally unlock competition, lower drug costs, and expand patient access, while warning that outdated regulatory barriers, patent tactics, and PBM practices continue to block affordable medicines from reaching the market. The piece makes the case for science-based regulation, congressional action on interchangeability, and a more competitive system that delivers real savings to patients.
We already know that one clear way to reduce the cost of medications is through the increased uptake of biosimilar therapies. Unfortunately, the US regulatory environment, in addition to the significant patent games employed by brand pharmaceutical companies, has significantly choked off that opportunity, as evidenced by the growing void in the marketplace. Projections showed that, while 118 biologics will lose patent protection between 2025 and 2034, only 12 of these medicines have biosimilars in development.
Because of this or similar concerns, many regulatory agencies worldwide have already updated their biosimilar policies to reflect modern science. Now, with the US Food & Drug Administration’s October 2025 announcement, the US has a rare opportunity to not just catch up, but to lead in getting more lower-cost biosimilar medicines available to patients.
Streamlining development by eliminating comparative efficacy studies will accelerate approvals – bringing biosimilar options to the market faster. Ultimately, this lowers patients’ costs at the pharmacy. Additionally, reforming interchangeability will remove statutory friction that has never reflected scientific reality. Together, these changes can strengthen the biosimilar market, reduce drug spending, and change the lives of patients being treated for conditions like cancer, Crohn’s disease and arthritis.
Much of this is not a US-specific issue – in fact, our partners at the International Generic and Biosimilar Medicines Association (IGBA) released a highly circulated and often referenced paper in June of 2024, calling for the streamlined development through reduced clinical studies.
But at a moment when the cost of healthcare remains a top list of concern for Americans, the US has a significant opportunity to turn scientific progress and innovation into real-life relief – both clinically and at the cash register. The FDA’s October 29 announcement calling to reform and streamline biosimilar development and modernise interchangeability is one of the most important steps yet – expanding access to safe, effective, more affordable biologic medicines.
The FDA’s reforms address this growing crisis by bringing the regulatory framework closer to global best practices and advancing policies long championed by patients, providers, and biosimilar manufacturers. At its core, this effort reflects a basic scientific truth: biosimilar development should be guided by modern analytics, not outdated conventions.
A central component of the FDA’s action is its updated position on comparative efficacy studies. For years, the scientific rationale has been clear: biosimilarity can be demonstrated through advanced analytics and pharmacokinetic data. Comparative efficacy studies, by contrast, are “blunt tools” that add high cost and time but little scientific value. The FDA’s own experience reinforces this. When biosimilars encounter approval issues, they arise from analytical data, not from comparative efficacy studies. No biosimilar has ever failed a clinical study without also failing analytically. Eliminating unnecessary comparative efficacy studies, while bluntly logical, will also have a significant impact. Analysts estimate that removing redundant clinical requirements can reduce development costs by tens of millions of dollars per product and shorten market entry timelines by more than a year. This type of positive change is what enables more companies to enter the market, leading to healthy competition and lower prices.
The FDA also signalled plans to finalise guidance removing switching-study requirements for “interchangeable” biosimilars. Globally, all approved biosimilars are treated as interchangeable. The US has been stuck as an outlier in this space, maintaining a separate legal category that is confusing to physicians, patients and insurers. This is a statutory issue, and the FDA cannot solve it alone. Congress created the interchangeability designation, and only Congress can modernise it. Thankfully, the bipartisan Biosimilar Red Tape Elimination Act offers a clear path forward. This bill would presume that an FDA-approved biosimilar is interchangeable with its reference product, eliminating unnecessary switching studies and aligning US policy with scientific consensus. This reform would help ensure lower-cost biosimilars can be substituted at the pharmacy counter, exponentially improving access across the country.
The combination of FDA leadership and US Congressional action can finally unlock the full promise of biosimilars. Patients cannot wait another decade for affordable medicines that already exist. Congress should move quickly to modernise interchangeability, support science-based regulation, and ensure that policies match the enormous potential of our industry. The FDA has taken a major first step. Now policymakers must finish the job.
And though the momentum driving positive change for biosimilars is exciting and promising, it doesn’t mean we can ignore other issues that put access to medications and treatments at risk. Specifically, the Pharmacy Benefit Manager (PBM) problem remains central to blocking patient options to lower-cost generic and biosimilar medications. Formularies too often prioritise products with the largest rebates rather than the lowest prices. Newly approved generics wait months, and sometimes even years, for coverage, even when they have the potential to generate immediate savings. And biosimilars priced 80 percent lower than biologic reference products can spend their first year on the market halted by PBM practices, leaving them stuck behind the very drugs they were meant to replace. Plus, recent findings in this Hunterbrook article question the transparency of the largest and most powerful US PBMs.
At the Association for Accessible Medicines and the Biosimilars Council, we remain committed to working on behalf of patient access in 2026 and beyond. The opportunity before us is significant – and with the right choices, this can be a year in which policymakers help America’s patients thrive, strengthening the future of affordable medicines for all.
