FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

At a moment when high drug prices continue straining families and the healthcare system, the US finally has a clear opportunity to turn scientific progress into real relief for millions of patients. The FDA’s October 29, 2025, announcement of reforms to streamline biosimilar development and modernize interchangeability is one of the most important steps yet—expanding access to safe, effective, more affordable biologic medicines. But realizing that potential now requires Congress to act. FDA has opened the door; policymakers must walk through it.

The US faces an escalating drug-pricing problem that could be addressed through the increased uptake of biosimilar therapies. Unfortunately the regulatory environment has historically choked off that opportunity, as evidenced by the growing void in the marketplace. Projections show that, while 118 biologics will lose patent protection between 2025 and 2034, only 12 of these medicines have biosimilars in development.

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core, this effort reflects a basic scientific truth: biosimilar development should be guided by modern analytics, not outdated conventions.

The announcement included draft guidance reevaluating whether comparative efficacy studies (CES) are needed for approval, along with a commitment to finalize long overdue reforms to the “interchangeability” designation. Together, these steps could cut years from development timelines, reduce costs, and accelerate competition—a transformative combination for patients with chronic conditions such as arthritis, cancer, Crohn disease, psoriasis, and asthma.

Ending the Era of Unnecessary Clinical Trials

A central component of FDA’s action is its updated position on CES. For years, the science has been clear: biosimilarity can be demonstrated through advanced analytics and pharmacokinetic data. CES, by contrast, are “blunt tools” that add significant cost and time but little scientific value.

FDA’s own experience reinforces this. When biosimilars encounter approval issues, they arise from analytical data, not CES. No biosimilar has ever failed a clinical study without also failing analytically. This makes sense. Biologics act like precise lock-and-key systems. Analytical testing accurately predicts safety and effectiveness, and strict manufacturing standards apply equally to biosimilars and reference products.

Eliminating unnecessary CES will 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 timelines by more than a year. Those savings are what enable more companies to enter the market, increase competition, and lower prices.

Interchangeability: A Statutory Problem Congress Must Solve

FDA also signaled plans to finalize guidance removing switching-study requirements for “interchangeable” biosimilars. Globally, all approved biosimilars are treated as interchangeable. The US remains an outlier, maintaining a separate legal category that confuses physicians, patients, and insurers. This is a statutory issue. FDA cannot solve it alone. Congress created the interchangeability designation, and only Congress can modernize it.

The bipartisan Biosimilar Red Tape Elimination Act offers a clear path forward. The 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, improving access across the country.

A Chance for the US to Lead—Not Lag Behind

Regulators worldwide have already updated their biosimilar policies to reflect modern science. With the FDA’s announcement, the US has a rare opportunity not just to catch up but to lead.

Streamlining development by eliminating CES will reduce costs and accelerate approvals. Reforming interchangeability will remove statutory friction that has never reflected scientific reality. Together, these changes would strengthen the biosimilar market, reduce drug spending, and increase access to life-changing treatments.

The Path Forward Is Clear—and Urgent

The combination of FDA leadership and 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 modernize interchangeability, support science-based regulation, and ensure that policies match the enormous potential of this market.

The FDA has taken a major step. Now policymakers must finish the job. The US can improve patient outcomes, lower health care costs, and enhance American competitiveness—but only if we act now.

Author Bio

Alex Keeton is the executive director of the Biosimilars Council. He leads the policy team for the Association for Accessible Medicines.