Another piece of bipartisan legislation was introduced last week that seeks to promote biosimilars.
Another piece of bipartisan legislation was introduced last week that seeks to promote biosimilars.
Senator Mike Enzi, R-Wyoming, and Senator Maggie Hassan, D-New Hampshire, unveiled legislation to enhance education about biosimilars in an effort to increase competition and lower the cost of biologics.
According to a joint statement, the bill has 3 main parts: requiring HHS to create a central website for educational resources on biosimilars; requiring the HHS secretary to establish a database to help medical professionals easily compare data associated with biologic and biosimilar products; and establishing incentives for medical providers to learn more about biosimilars.
It aims to boost the confidence level of both physicians and patients regarding biosimilars’ safety and effectiveness.
The 2 senators cite the slow uptake of biosimilars in the US market, saying that while just 2% of Americans use biologics, they make up 40% of total spending on prescription drugs.
“We are not benefiting from cheaper prescription drug alternatives like biosimilars as much as we should,” Enzi said. “Biosimilars are one of the ways we can do something about healthcare costs without just shifting them elsewhere in the system or implementing administrative price controls. This legislation would help increase confidence in lower-cost biosimilar products, which could drive down drug costs for Americans.”
“Biosimilars have the potential to reduce how much Granite Staters and Americans are spending on drugs, but there is a lack of awareness about these products,” Hassan added. “This bipartisan legislation would help improve awareness and understanding of biosimilars, which in turn could help increase the use of these products and save money for consumers and the federal government.”
A 2017 study by the RAND Corporation estimated the cost savings potential of biosimilars to be $54 billion over 10 years.
Also last week, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released a bill that includes several components related to biosimilars, including one that would require updates to the FDA’s Purple Book, which provides stakeholders with information on biologics. Another part addresses the abuse of citizen petitions.
In addition, that bipartisan bill, sponsored by chairman Lamar Alexander, R-Tennessee, and ranking member Patty Murray, D-Washington, stipulates that the FDA would be required to establish a website for stakeholder education on biologics, including biosimilars and interchangeable products, and allows for the development and improvement of continuing medical education for providers on these topics.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.