The Biosimilars Forum Calls for State Policies that Support Lower-Cost Prescription Drugs Including Biosimilars for Patients that Need Them

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the Colorado Prescription Drug Affordability Board set an Upper Payment Limit.

“Federal and state governments must support policies that lower prescription drug costs for Americans and support a sustainable and thriving biosimilars market. The Forum is very concerned with the Colorado Prescription Drug Affordability Board’s (PDAB) action to place artificial price controls on a biologic with biosimilar competitor, which are often up to 85% less expensive than brand biologics. This action negatively impacts patients that need access to lower-cost medicines. The action could also deter biosimilars manufacturers from continuing their work developing lower-cost biosimilars.

“It is crucial for patients to have the ability to access FDA-approved, lower-cost biosimilars. Biosimilars should not be included as potential products that may be subject to an Upper Payment Limit (UPL). Lawmakers should focus, instead, on policies that support patients and their access to biosimilars. The potential application of a UPL to biosimilars raises serious concerns about the ability of biosimilar to continue to exert competitive pressures on prices of reference products and on other biosimilars and to sustain the industry.  

“Biosimilars are a commonsense, bipartisan solution to skyrocketing prescription drug prices. Unfortunately, the biosimilar market is not thriving. In fact, if market dynamics do not significantly change, the long-term market sustainability is in peril, and the cost-savings potential of biosimilars could be lost forever.

“State lawmakers can lower prescription drug costs for the patients by championing lower-cost, U.S. Food and Drug Administration (FDA)-approved biosimilars. These medicines, which reference originator biologics, are a commonsense free-market solution to rising drug prices plaguing Americans and the U.S. healthcare system. The biosimilars industry continues to prioritize cost-savings to both patients and the healthcare system as the healthcare affordability crisis worsens.  

“Biosimilars can help address waste and excessive spending in government programs. Prices continue to rise for reference biologic drugs, which were 46% of U.S. prescription drug spending in 2022 despite only making up 3% of prescriptions. Patient and taxpayer spending on biologics increased from $100 billion to $260 billion (adjusted for inflation) over the last decade. These risings costs hit American seniors, small businesses, and middle-class families the hardest.

“Biosimilars have been associated with savings of $56 billion. The next five years could see an increase in savings up to $181 billion for Americans and the healthcare system. However, time is of the essence as the biosimilars industry faces a looming ‘biosimilars void.’

“A typical biosimilar costs $100 million to $300 million to develop and takes six to nine years to go from the initial stages of development to FDA approval—requiring a major investment from U.S. companies. Our members take immense pride in this investment, and they must ensure their products are approved with efficiency to reach Americans that need them.

“This is especially pertinent as a ‘biosimilar void’ comes into view. Over the next decade, 118 biologics are expected to lose patent protection, and biosimilars could offer significant cost-savings for each of these. Unfortunately, only 10 percent currently have biosimilars in development, while 90 percent have no biosimilar in the pipeline. This void in the biosimilar market significantly limits savings potential to the healthcare system.”

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.