The Biosimilars Forum Commends Commissioner Makary and the FDA for Streamlining Development of Lower-Cost Biosimilars   

The FDA Is Prioritizing Making Prescription Drugs More Affordable for Americans 

FOR IMMEDIATE RELEASE 

March 10, 2026 

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the U.S. Food and Drug Administration (FDA) announced updated guidance to streamline biosimilar development: “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4). 

“The Biosimilars Forum commends the FDA and Commissioner Makary for taking steps to streamline unnecessary three-way clinical pharmacokinetic (PK) testing when scientifically justified. This change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs, according to the FDA. Commission Makary’s leadership will help bring more biosimilars to the market more quickly, ensure those biosimilars can reach patients, and lower everyday healthcare costs for Americans.  

“The Forum and our members applaud Commissioner Makary and the FDA for their commitment to lowering drug costs for Americans by utilizing commonsense reforms to modernize the agency and use more precise analytical testing approaches. Commissioner Makary is empowering the hardworking and talented staff at FDA to support the Administration’s goals of lowering prescription drug costs.  

“Importantly, this announcement builds on the progress of the FDA’s October 2025 measures on additional streamlined development guidance, which is having an impact on lowering prescription drug prices for Americans. Biosimilars are often up to 50% lower cost than reference biologics. 

“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 appreciate the FDA taking steps to ensure their products are approved with efficiency to reach Americans that need them. 

“Ensuring biosimilars reach the market and 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 savings potential to the healthcare system, and steps to streamline development mitigatesthe detrimental impact the void could have on the industry. 

“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 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.  

“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, and biosimilars can provide critical relief for communities across the nation.” 

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

Note on Updated Guidance: Specifically, this draft guidance provides updated recommendations to prospective biosimilar applicants seeking to use data from a comparator product approved outside the U.S. (“non-U.S.-licensed comparator product”) as evidence that a proposed product is biosimilar to the U.S.-licensed product. The recommendations describe scenarios in which a biosimilar applicant may use clinical data from outside the U.S. without additional data from a three-way PK study (using the proposed biosimilar, the U.S.-licensed reference product, and the non-U.S.-licensed comparator product). The revisions also remove the earlier recommendation for at least one clinical PK study that directly compares the proposed biosimilar with the U.S.-licensed reference product to support a demonstration of biosimilarity; instead, a PK study can use a comparator product approved outside the U.S. if scientifically justified.