Biosimilars Forum Supports Senate Finance Committee Legislative Discussion Draft Promoting Biosimilars
Juliana M. Reed, executive director the Biosimilars Forum, released the following statement announcing the Biosimilars Forum’s support for the Senate Finance Committee’s latest legislative discussion draft. The Committee’s discussion draft contains provisions supporting high-discount biosimilars. The draft includes recommendations that starting in 2026, Medicare Part D plans must adhere to new rules covering “high-discount biosimilars,” which are biosimilars priced at least 45% less than their reference biologics.
“The Biosimilars Forum is proud to support the biosimilars policies outlined in the Senate Finance Committee’s latest legislative discussion draft. These policies promote uptake, access, and availability of lower-cost biosimilars within the Medicare Part D program. Increased access to biosimilars for Medicare patients is a win for everyone. Biosimilars are a commonsense bipartisan solution to skyrocketing prescription drug costs, and the Forum is looking forward to bringing the cost-savings promise of these treatments to reality.
“The Committee’s discussion draft promotes the use of safe, effective, and lower-cost biosimilars through provisions requiring Part D plans to offer biosimilars to Medicare beneficiaries. This effort will directly lead to lower costs for patients.
“Eight Humira® adalimumab biosimilars have launched this year with virtually no uptake among Medicare Part D patients. These critical treatments should be readily available to seniors on Medicare when they have significantly lower prices than the reference product. However, the lack of Medicare formulary access means that patients cannot experience these cost savings. The discussion draft addresses this specifically by stating that “beginning with plan year 2026, Part D plans meet certain coverage and cost-sharing requirements with respect to “high-discount biosimilars…”
“The discussion draft also highlights that “On a biannual basis, CMS will release a list of biosimilars that qualify as high-discount biosimilars for particular reference products.” This ongoing, midyear access for biosimilars will benefit patients by making lower-cost treatments more readily available.
“The ongoing lack of access to more affordable biosimilars has prevented free-market competition from working – limiting patient savings and harming the long-term sustainability of future biosimilar development. This discussion draft is an important first step in promoting access to these life-saving treatments for patients. The Forum strongly encourages the Committee to move forward with these crucial provisions.
“During a watershed year for biosimilars, this discussion draft is critical for the uptake and availability of biosimilars in the Medicare Part D program. In a year that saw eight lower-cost biosimilars launched referencing the world’s best-selling drug, Humira®, pharmacy benefit managers (PBMs) have stifled uptake of these products despite their costs being up to 85% lower than Humira®. Humira® can cost upward of $84,000 annually and has risen in price 470% since first introduced. The adalimumab biosimilars for Humira® offer significant cost-savings, but access to these lower cost biosimilars is being blocked. Uptake for these treatments if virtually zero, which is a failure of the U.S. healthcare system.
“The dismal uptake and access for the Humira® adalimumab biosimilars are staggering. Out of 42,000 potential patients, less than 1,000 have received access to a biosimilar. In fact, Medicare Part D has the lowest utilization of the low-cost, Humira® biosimilars. Of the eight biosimilars that have been launched, six have pricing structures with a low-cost, low-rebate option. The discounts range from 5% to 86%. Patients deserve access to these lower-cost options.
“This current reality is unacceptable. Patients must be able to fully access FDA-approved, lower-cost biosimilars. When formularies, especially Medicare formularies, prioritize high cost, high rebate products, patients suffer. Lawmakers on the Hill must intervene to deliver on policies that provide more affordable biosimilars to those who need them so that we can continue to deliver on our commitment to bring competition and lower cost biosimilars to patients.
“Biosimilars save money. In fact, a competitive biosimilars market can save patients and the U.S. health care system $133 billion by 2025. The Medicare program alone could have saved millions and millions of dollars if all biosimilars had been used as frequently as the most-used biosimilars.
For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.