The Biosimilars Forum Commends Members of the House of Representatives Energy & Commerce Committee for Supporting Lower-Cost Biosimilars  

Lawmakers Prioritized Affordability for Americans by Moving Key Bipartisan Bills that Will Increase Access to Lower-Cost Biosimilars

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the House Energy & Commerce Committee voted unanimously to move to the floor the Expedited Access to Biosimilars Act and the Biosimilar Red Tape Elimination Act, which are bipartisan bills that would increase access to biosimilars to Americans that need them.

“The Biosimilars Forum and our members applaud the Energy & Commerce Committee for moving forward the Expedited Access to Biosimilars Act and the Biosimilar Red Tape Elimination Act. These efforts will help bring more biosimilars to the market more quickly, ensure those biosimilars can reach patients, and lower everyday healthcare costs for Americans. These policies directly support FDA’s efforts to modernize the agency and use more precise analytical testing approaches.

“The Forum especially thanks Chairman Guthrie, Ranking Member Pallone and Representatives Pfluger, Langworthy, Auchincloss, Schrier, and Landsman for their steadfast commitment to lower-cost biosimilars. Their work will address affordability concerns and bring a host of benefits to the American people, from introducing more competition to giving patients choice of treatment to lowering prescription drug costs.

“I thank the members of the Biosimilars Forum for their leadership in helping deliver lower-cost, safe and effective medicines. The Forum’s member companies are dedicated to providing patients with the medicines they need.

“Nearly 30% of Americans say they have not taken their medication as prescribed due to unaffordable prices. FDA-approved biosimilars are on average more than 50% lower-cost than the originator biologics they reference. Biosimilars are a key component of the solution to fix America’s healthcare affordability crisis. 

“Today, more than 90 biosimilars have been approved by the FDA in the United States across dozens of disease states. The potential of biosimilars is enormous. To date, biosimilars have been associated with savings of $56 billion, but with support from the Administration and Congress, this number can be much higher. In fact, the next five years could see an increase in savings up to $181 billion for Americans and the healthcare system. 

“Ensuring biosimilars reach the patients is especially important considering the ‘biosimilar void.’ Of the 118 biologics expected to lose patent protection over the next decade, only 10 percent currently have biosimilars in development. This void in the biosimilar market significantly limits potential savings to the healthcare system, and steps to streamline development and approval can help mitigate its detrimental impact on the industry.

“Prices continue to rise for reference biologic drugs, which were 51% of U.S. prescription drug spending in 2024, despite only making up 5% of prescriptions. Patient and taxpayer spending on biologics increased from $100 billion to $260 billion (adjusted for inflation) over the last decade. These rising costs hit American seniors, small businesses, and middle-class families the hardest, and biosimilars can provide critical relief for communities across the nation.

“This is an important step in making biosimilars more readily available and accessible to patients, but more must be done to ensure the promise of biosimilars is fully realized. The Biosimilars Forum looks forward to continued work with Administration officials, the FDA, and Congress.”

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

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MEDIA CONTACT:

Scott Lusk

Signal Group, Managing Director

202-288-3233; slusk@signaldc.com