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Policies

As the 119th Congress convenes, policymakers have a historic opportunity to champion lower-cost, U.S. Food and Drug Administration (FDA)-approved biosimilars. These medicines, which reference originator biologics, are a free-market solution to rising drug prices plaguing Americans and the U.S. healthcare system. In the last ten years, biosimilars have been associated with savings of $56 billion compared to what spending would have been without biosimilars. The next five years could result in an increase in savings up to $181 billion as newly approved biosimilars launch and existing biosimilars see continued uptake and price reductions. These cost-savings will be critical to providing access and coverage for millions of Americans for new innovations, such as GLP-1s and new treatments for conditions like cancer. The biosimilars industry continues to prioritize cost-savings to both patients and the healthcare system as the healthcare affordability crisis worsens.

In addition to increasing access to lower-cost medicines, cost-savings from biosimilars are a critical solution to creating savings in government healthcare programs and eliminating wasteful government spending. President Trump, his Administration, and this Congress have the opportunity to utilize cost-savings from biosimilars to solidify Medicare’s funding.

The introduction of biosimilars leads to lower costs and offers increased access to patients – a clear win for this Administration and Congress. Biosimilars are, on average, more than 50% lower-cost than the biologics they reference. Powered by the work of American biopharmaceutical companies, the emerging biosimilars industry celebrated a milestone earlier this year, with the 60th biosimilar approved for use by the FDA. These 60 approved biosimilars include ten biosimilars for Humira, the world’s best-selling drug that can cost up to $84,000 annually, the biosimilars on the market today are 85% lower cost than the brand drug, yet Pharmacy Benefit Managers (PBMs) are blocking patient access to these lower cost biosimilars.

To achieve the significant cost-savings opportunity that biosimilars represent to the country, Congress must address the PBMs that are blocking access and competition. Congress must pass PBM reform NOW.

The exploitative practices of PBMs toward patients, pharmacists, and overall fiscal responsibility is well-known. The three major PBMs that control more than 80% of the prescription drug marketplace have profited by putting Americans on more expensive drugs—intentionally circumventing lower-cost biosimilars. These deceitful practices are systemic—so much so that the Senate Finance Committee and Federal Trade Commission (FTC) each found the same conclusion as House Oversight: PBMs operate in ways that hurt patients. The House Oversight Committee, under the leadership of Chairman James Comer, revealed in 2024 that anticompetitive and monopolist PBMs have collaborated to push more expensive drugs onto patients and undermine local pharmacies that millions of Americans rely on. There have been few classes of drugs more impacted than biosimilars.

As we approach the March deadline for a new continuing resolution (CR), time is of the essence. It is imperative that a comprehensive PBM reform package be included in the near-term CR. Congress has the chance to end the prescription drug affordability crisis once and for all, while saving Medicare billions of dollars. Patients should not face sky-high prescription drug prices and fewer options for the treatments they need because of market domination by originator biologics and monopolistic practices from PBMs.

The Biosimilars Forum and its member companies are eager to roll up our sleeves and work on solutions that eliminate government waste, protect free market competition, support American businesses, and deliver relief to patients who cannot afford their critical medications. The companies provide Americans jobs and support Americans who need life-saving medicines.

We are looking forward to working on the issue of PBM reform as well as several priorities to benefit Americans, including:

  • CMS must update the IRA Biosimilars Special Rule to provide confidence that biosimilar manufacturers need to continue costly development programs. An ongoing stable market that relies on free market competition is necessary to eliminate unfair barriers to competition that the industry is facing.
  • CMS must prioritize policies that increase access to lower-cost biosimilars in Medicare Part B and Medicare Part D. This will achieve significant cost-savings to make the Medicare program sustainable and create budget for new and innovative treatments for conditions like obesity and cancer.
  • FDA must become more efficient in reviewing and approving biosimilars. Streamlined development and review of biosimilars will ensure the industry continues to develop new medicines to treat diseases and lower costs. Biosimilars increase competition, provide more options for patients, and lower costs across the entire healthcare industry.
  • Congress must prioritize policies that support the long-term viability of the biosimilar industry. This will benefit American patients, providers, employers, veterans, and more through lower-cost prescription drugs and new life-save medicines for diseases.

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