Schrader and Kinzinger Introduce Bipartisan Biosimilar Bill to Lower Drug Costs

Press Release

Date: April 23, 2021
Location: Washington, DC

Congressman Kurt Schrader (OR-05) and Congressman Adam Kinzinger (IL-16) introduced H.R.2815, the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act. This bill would increase reimbursements for biosimilar drugs, boosting their utilization by doctors and result in lower cost-sharing for patients.

U.S. Food and Drug Administration (FDA) approved biosimilars are drugs that work in the same way, at the same dose with a slightly different substance than an FDA-approved biologic, which is known as the reference product. Biosimilars highly resemble the reference product because there are no clinically meaningful differences, utilizing the same pathway for treatment, and biosimilars must also undergo rigorous FDA testing standards. These drugs are injected or infused rather than taken in pill-form, which generally requires administration in a provider's office. Common uses for both biosimilars and biologics include treatment for cancer and rare diseases.

While the two products are decidedly alike, the main difference between biosimilars and biologics surrounds price: biosimilars are newer, low-cost alternatives to biologics, which are generally among the most expensive drugs on the market. Despite this difference, the use of biosimilars in the U.S. has remained much smaller than their share of the marketplace. The BIOSIM Act aims to close this financial gap by temporarily increasing the reimbursement for biosimilar drugs from the average sales price (ASP) of the drug plus 6% to the ASP of the drug plus 8% for five years to help increase their usage by doctors. Currently, Medicare patients pay a 20% coinsurance on Part B drugs, which both biologics and biosimilars are classified as. Most of the U.S. Government's spending on drugs in Medicare is on these expensive drugs, but by incentivizing a substantial increase in these similar alternatives, patient cost-sharing and government spending will decrease. An example of this can be seen in Europe, where biosimilars have replaced expensive biologics, as often as 90% of the time in some cases.

"There is no doubt the BIOSIM ACT is a win-win, saving big money for patients and our government," Rep. Schrader said. "Biosimilars have long struggled to gain traction in the market, but by incentivizing the use of the lower cost product, they will finally compete with high-cost biologics. This would mean costs for the healthcare system, government and patients -- especially seniors -- would all go down as we transition to a greater use of these lower cost biosimilar drugs."

"One of the most consistent issues I hear about from my constituents is the rising cost of prescription drugs, and the impact those costs have on them and their family. We have a duty to ensure patients are receiving the most affordable option available and that our policies encourage competition to drive prices down," said Rep. Kinzinger. "The BIOSIM Act aims to lower prices by increasing the utilization of a more affordable alternative to biologics -- called biosimilars. As biosimilar utilization goes up, prices for patients will go down."

"As the next generation of generics, biosimilars are the way we lower drug spending," said Meaghan Smith, Executive Director of the Biosimilars Forum. "Seniors should be able to afford their medications, but originator biologics make up the top ten most expensive drugs in Medicare Part B and backwards incentives are preventing patients from accessing the lower-cost biosimilar. Thanks to Congressman Schrader for his leadership and work to find common-sense, bipartisan solutions to lower health care costs. This bill will help correct those backwards incentivizes and help patients and taxpayers save money with lower-cost biosimilars."

"The BIOSIM Act addresses one of the barriers to greater biosimilar adoption by providing a temporary increase in reimbursement (ASP+8%) to physicians and hospitals when they use a biosimilar," said Christine Simmon, Executive Director of the Biosimilars Council.

"Biosimilars are critical treatments for America's patients and The BIOSIM Act would take an important step in advancing biosimilar use and savings in the U.S.," added Dan Leonard, President & CEO of the Association for Accessible Medicines (AAM). "The Association for Accessible Medicines and its Biosimilars Council are pleased to offer our support and endorsement of The BIOSIM Act."

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