The Increasing Access to Biosimilars Act of 2023 Introduced to Congress

The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would improve biosimilar accessibility, was introduced to the House of Representatives.

The bill was written by Representative Richard Hudson (R-North Carolina) and was referred to the Committee on Energy and Commerce and the Committee on Ways and Means.

If the bill becomes law, HHS will be required to establish and implement a 3-year nationwide demonstration project under part B of title 18 of the Social Security Act within 1 year of the date of enactment. The project will be used to evaluate the benefits of providing a shared savings payment for future biosimilar products.

Participation in the demonstration project would be voluntary and participating providers may quit the project at any time. Additionally, the HHS secretary would have the power to terminate a providers’ participation at any time. Participating in the project would not interfere with a provider’s eligibility from participating in other models authorized under section 1115A of the Social Security Act, such as the Oncology Care Model and the Oncology Care First Model.

Juliana M. Reed, executive director of the Biosimilars Forum, praised the bill in a statement, saying, “The members of the Biosimilars Forum and I thank Congressman Hudson for introducing this vital piece of legislation, which would help make biosimilars more accessible. Biosimilars can save the health care system $133 billion by 2025 if they are fully available and accessible to the patients who need them. Health equity and maximizing cost-savings for patients are at the forefront of the Biosimilars Forum’s mission. A shared savings reimbursement model can significantly close health equity gaps and deliver treatments to individuals and communities who need them most.”

Regarding payment, the bill states that in addition to the payment that would otherwise be made for a biosimilar that would be dispensed by a participating provider, an additional payment determined by the HHS secretary must be made. The secretary would base the amount on the cost to the provider for furnishing the biosimilar and the cost to the provider if they furnished the reference product. However, the additional payment must not result in the increases to a Medicare beneficiary’s coinsurance. Providers would only receive the additional payment if the amount for the biosimilar is less than the payment amount for the originator.

“2023 is a watershed year for biosimilars in the United States – led by the launch of eight Humira biosimilars, referencing the world’s best-selling drug. This make-it-or-break-it year for the biosimilars industry requires the full support of policymakers and stakeholders to provide patients with the lower-cost treatments they deserve. I look forward to working with lawmakers on both sides of the aisle to get this moment right and deliver lower-cost biosimilars for patients,” said Reed.

At the end of the 3-year period, the HHS secretary would have to submit to Congress a report on whether the project should be expanded or extended.