The Biosimilars Forum Commends Members of the Senate HELP Committee for Supporting Lower-Cost Biosimilars  

This Bill Will Accelerate Safe and Effective Biosimilar Development by Eliminating Unnecessary Bureaucratic Inefficiencies

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the Senate Committee on Health, Education, Labor and Pensions (HELP) advanced the Expedited Access to Biosimilars Act to lower drug costs by modernizing the development and approval process for biologics to make it more efficient. This policy importantly includes signatory authority for the FDA’s Office of Therapeutic Biologics and Biosimilars.

“The Biosimilars Forum applauds the members of the Senate HELP Committee for moving forward the Expedited Access to Biosimilars Act, which will help patients have access to more lower-cost biosimilars more quickly. Biosimilars are a key component of the solution to fix America’s healthcare affordability crisis. The Forum and our members especially thank Senators Ashley Moody, Rick Scott, Angela Alsobrooks, and Lisa Blunt Rochester for their commitment to supporting healthcare affordability and lower-cost, safe, and effective biosimilars.

“The HELP Committee rightfully recognizes the importance of developing biosimilars efficiently based on science, rather than being slowed down by bureaucracy. This policy will help empower the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) with signatory authority on biosimilar reviews and applications. The FDA’s OTBB office created the biosimilar industry in the U.S. from the ground up, and its personnel simply know the science best and should be empowered.

“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. 

“Americans deserve to be able to afford the treatments they need for serious conditions such as cancer, autoimmune diseases, diabetes, and more. We are excited to see members of Congress prioritize American patients who want access to affordable, safe, and effective medicines.

“The FDA has approved than 90 biosimilars in the U.S., and the potential cost-savings for patients and the healthcare system is enormous. Biosimilars have been associated with savings of $56 billion. If access increases, the next five years could see an increase in savings up to $181 billion for Americans and the healthcare system — only possible through commonsense policy changes like today’s efforts.

“This 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 harms patients and significantly limits potential savings to the healthcare system.

“The Biosimilars Forum looks forward to continued work with Administration officials, the FDA, and Congress. More must be done to ensure the promise of biosimilars is fully realized.”

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