Two biosimilar bills, both with bipartisan sponsors, were unveiled last week and aim to boost uptake in the United States, one through increased Medicare payment and the other via additional education.
Two biosimilar bills, both with bipartisan sponsors, were unveiled last week and aim to boost uptake in the United States, one through increased Medicare Part payment and the other via additional education.
Payment for biosimilars in Medicare Part B would get a temporary boost through the Bolstering Innovative Options to Save Immediately on Medicines Act (BIOSIM), which would temporarily increase reimbursement for biosimilar drugs to the average sales price (ASP) plus 8%, up from the current 6% plus ASP. The larger payments would last for 5 years in an effort to help increase their utilization by doctors administering the drugs.
Medicare patients pay a 20% percent coinsurance on Part B drugs; spending on Part B drugs totaled $21.5 billion in 2014.
The BIOSIM Act is from Rep. Kurt Schrader, D-Oregon, and Rep. Greg Gianforte, R-Montana.
“Biosimilars have long struggled to grow in utilization and the BIOSIM Act will help them gain market share by providing an incentive for biosimilars that are lower cost than the biologic,” Schrader said in a statement. “Costs for patients and the healthcare system will go down with the transition to greater use of lower cost biosimilar drugs. There is no doubt that this bill is a win-win for patients and providers.”
Gianforte added, “I often hear from Montanans about the skyrocketing costs of their prescription drugs and the challenges they face to pay for them. This bipartisan bill provides incentives for using biosimilar drugs over biologics. With increased use of biosimilars, patients will see lower out-of-pocket costs for the medications they need, and taxpayers will save money.”
The Biosimilars Forum, which represents biosimilar drug makers, praised the introduction of the act, saying in a statement that “This legislation will help guide physicians to lower-cost, safe, and effective treatment options that reduce the financial burden for both patients and taxpayers. Enhancing provider reimbursements through an increased ASP add-on is essential to increasing biosimilars uptake and saving billions of taxpayer dollars.”
In another bill, Representatives Eliot Engel, D-New York, and Larry Bucshon, R-Indiana, introduced the Advancing Education on Biosimilars Act of 2019. This bill is a companion bill to one introduced in the Senate earlier this year by Senators Mike Enzi, R-Wyoming, and Maggie Hassan, D-New Hampshire. Their bill, S. 1895, the Lower Health Care Costs Act, passed the Senate Committee on Health, Education, Labor and Pensions in June.
The bill would create federal programs to promote biosimilars, including the development of continuing education programs for healthcare providers. In addition, the bill would require the FDA to create a public website to educate patients and providers about biologics and biosimilars, including providing information about interchangeability and processes for reporting adverse events that pose a risk to patient health and safety.
The American Hospital Association supports the public education bill.
“America’s hospitals and health systems thank Reps. Engel and Bucshon for their bipartisan efforts to facilitate the increased use of biosimilar drugs, including the importance of interchangeability, by educating providers, patients and other key stakeholders on their clinical value,” said Tom Nickels, AHA executive vice president, in a statement. “This will give patients greater access to affordable, innovative drugs.”
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
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.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
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.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.