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Legislation on generics, biosimilars headed to Biden's desk

The two pieces of legislation — one focusing on generics, another on biosimilars — are aimed at lowering healthcare costs for consumers.
Sandra Levy
Senior Editor
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Two bills that will have an impact on lowering healthcare costs for consumers are headed to President Biden to be signed into law.

The first bill focuses on generics, while the second bill highlights biosimilars.

U.S. Senator Tina Smith’s, D-Minn. bipartisan legislation to help lower prescription drug costs is headed to the President Biden’s desk to be signed into law after passing the House on April 14,  and passing the Senate in March.

The Ensuring Innovation Act, led by Sen. Smith and Sen. Bill Cassidy, R-La., will stop pharmaceutical manufacturers from claiming new innovations when they make insignificant modifications to their products in order to extend their monopolies and keep drug prices high for consumers.

Right now, pharmaceutical companies engage in “evergreening,” which allows them to extend their patents for five years when they make minor, insignificant changes to a drug. The Food and Drug Administration tried to end the practice by only granting these patent exclusivities to drugs that truly have a new chemical entity, but a district court decision invalidated the agency’s ability to block this practice. The Ensuring Innovation Act would ensure the FDA has the ability to curb this practice, according to the legislators.

“We need to stand up for Americans who are struggling to afford life-saving prescription drugs. This is especially important as we navigate the public health and economic crisis of COVID-19,” said Sen. Smith. “The House passage of our bipartisan Ensuring Innovation Act is important progress in the fight to make medications more effective and drive down costs for consumers. The next step is for President Biden to sign this into law. ”

“We must lower prescription drug costs. We can do this by increasing competition and closing loopholes which prevent generics from reaching the marketplace. This bill does both,” said Dr. Cassidy. “It’s good for your health. It’s good for your wallet. It’s a good piece of legislation.”

The second piece of legislation, was passed by the U.S. House of Representatives on April 14, and awaits President Biden's signature. It was introduced by U.S. Senators Maggie Hassan, D-N.H., and Bill Cassidy, R-La. to enhance education about biosimilar drug products. 

The Senators’ bipartisan Advancing Education on Biosimilars Act would help increase competition and lower the cost of biologic medicines.

Biologics are complex products that may be used to treat serious or chronic conditions, such as diabetes, rheumatoid arthritis, and certain cancers. Biosimilars are highly similar to and have no clinically meaningful differences from brand biologic drugs, but are manufactured by different companies. Independent studies have estimated that switching to biologics could save Americans up to $54 billion over 10 years in health care costs.  

“Biosimilar alternatives can help save lives and lower health care costs, but currently many doctors and patients in New Hampshire and across the country are in the dark about this affordable option,” Senator Hassan said. “I am glad that both chambers have passed our bipartisan legislation to improve education about biosimilar products, and I urge the President to sign this important legislation into law.”

“Passing this bill in Congress has the potential to lower prescription costs for patients, but also for taxpayers, because taxpayers pay a lot of the bill too,” said Dr. Cassidy. “This legislation improves awareness for the doctor, and the patient, that these drugs are effective and they’re less expensive. They’re good for your health. They’re good for your wallet. It’s a good piece of legislation.”

The Senators’ bipartisan legislation would provide educational materials to patients and providers to help improve confidence in the safety and effectiveness of these FDA-approved products. Improved confidence in biosimilars could lead to increased use, which in turn could increase health care savings.

Senators Hassan and Cassidy have previously worked together to help lower the cost of health care, and recently led successful efforts to include a provision in the year-end package that was signed into law to help end the absurd practice of surprise medical billing. Additionally, in 2019, President Trump signed into law bipartisan legislation introduced by Senators Cassidy and Hassan to close a loophole in the Medicaid rebate program that results in big pharmaceutical companies overcharging taxpayers. The bipartisan legislation will save taxpayers approximately $3.1 billion over the next 10 years.