House Ways and Means subcommittee hears experts on biosimilars, market barriers and funding cuts

WASHINGTON — Witnesses told the House Ways and Means subcommittee at a congressional hearing that biosimilar medicines can expand access and reduce costs for patients but face multiple market, regulatory and policy obstacles that are slowing adoption.

The hearing opened with the chairman noting the potential for biosimilars to “lower costs for patients and provide greater and more affordable access to care,” and a panel that included practicing physicians, a trade council executive and an academic expert described several specific impediments to wider use.

Biosimilars are highly similar versions of biologic drugs whose entry into the market has produced measurable savings, witnesses said. “Since entering the market in 02/2015, biosimilars have saved the entire health care system over $23,600,000,000,” Dr. Debra Pratt, president of the Community Oncology Alliance and a practicing oncologist in Austin, said in her testimony. Craig Burton, executive director of the Biosimilars Council, cited a separate estimate that biosimilars have yielded roughly $36 billion in system savings and expanded access by millions of patient-treatment days.

But witnesses and several members of the panel described how middlemen and policy design are limiting uptake. Dr. Colin Edgerton, a community rheumatologist, said pharmacy benefit managers, or PBMs, extract rebates that can push reimbursements below the cost of acquiring biosimilars, creating “underwater” situations in outpatient clinics that discourage physician use. “PBMs are true middlemen that are extracting billions of dollars from our health care system,” Edgerton said, and their formulary decisions can require practices to stock multiple biosimilars favored by different insurers.

Experts identified other structural barriers. Several witnesses urged changes to Medicare Part B payment rules so providers are not penalized financially for using lower-cost biosimilars, and recommended reforms to the average sales price (ASP) methodology and the add-on reimbursement that hospitals and physician practices receive. Burton and others also pointed to “patent thickets,” using Humira (adalimumab) as an example of a branded product burdened by large numbers of patents that delay biosimilar entry.

Panelists raised concern that the Inflation Reduction Act’s implementation and timing uncertainty around Medicare negotiation could discourage long-term investment in biosimilar development. “If you’re thinking about a $300,000,000 investment today … you want to be able to predict what that market’s going to look like,” Burton told the subcommittee.

Witnesses also warned that recent federal staffing and grant reductions are undermining the research and regulatory ecosystem that supports biologics and biosimilars. Dr. Aaron Kesselheim, who leads a program on regulation and therapeutics at Harvard Medical School, described cuts at the NIH, CDC and FDA and said those actions risk delaying or shrinking the scientific work that feeds future therapies. “Government-funded research is the engine of therapeutic innovation,” Kesselheim said, and he added that vacancies and firings at regulatory agencies would make timely, confident review and guidance more difficult.

Lawmakers pressed witnesses for policy solutions. Suggestions at the hearing included: clarifying and streamlining FDA requirements (for example reassessing when large clinical efficacy trials are necessary), reforms to patent-review procedures to reduce abusive layering of patents, requiring plan coverage of the lower-cost biosimilar by default, banning or limiting confidential rebate practices once biosimilars are available, and creating Medicare payment adjustments to ensure provider viability when using biosimilars.

Committee members from both parties described bipartisan interest in improving patient access and reducing costs, though they disagreed on the causes and remedies. Ranking Member Lloyd Doggett criticized industry practices and tax rules as part of the reason high drug prices persist, while others focused on the effects of federal policy such as the IRA and the impact of recent HHS personnel and grant decisions.

Several witnesses urged Congress to act to restore predictability for companies investing in biosimilars and to address PBM and reimbursement distortions that make adoption less reliable. As Burton summarized, “The presumption needs to be that patients should have access to the lower-cost biosimilar first.”

No formal legislative action or votes were recorded at the hearing; members said they would pursue written questions and potential follow-up proposals.