AAM, Biosimilars Forum call on CMS to support lower-cost biosimilars, increase access for patients

AAM and The Biosimilars Forum state that the uncertainty created by the IRA harms generic and biosimilar competition.

8/16/2024

The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, and the Biosimilars Council on Thursday, Aug.15 commented on the recent announcement from the U.S. Department of Health and Human Services regarding a fact sheet published by the Center for Medicare & Medicaid Services. The announcement aims to identify cost savings related to newly negotiated pricing for 10 select brand-name drugs.

“Today’s announcement by CMS only highlights the folly of this government price setting scheme. CMS projects average savings of 22% on these selected brand pharmaceuticals, a figure that pales in comparison to typical savings from generics and biosimilars,” said David Gaugh, interim president and CEO of AAM. “The data is clear: generic and biosimilar competition is the best way to deliver low-cost drugs for patients and taxpayers. The uncertainty created by the IRA harms generic and biosimilar competition. We call on policymakers to address patent thickets, PBM brand drug rebates and other root causes that delay generic and biosimilar competition, rather than doubling down on government price setting.”

Juliana M. Reed, executive director the Biosimilars Forum, released the following statement, echoing AAM's concerns:

“The Biosimilars Forum is greatly concerned that the Centers for Medicare & Medicaid Services is misinterpreting the Biosimilar Special Rule of the Inflation Reduction Act. Congress’s intent was to omit products from negotiation that will have imminent biosimilar competition, which would ultimately provide more choice to patients and lower prescription drug prices. The Forum calls on CMS to immediately adjust their draft guidance to align with Congressional intent of the statute, which will preserve free-market competition and lower prices for patients.

“The Forum supports lower drug prices for patients, and we believe free market competition is the best way to achieve this. CMS has the opportunity to promote competition that lowers prices and increases access for patients through lower-cost drugs, like biosimilars. Biosimilars can save the U.S. health care system up to $133 billion by next year if they are accessible.

“When Congress passed the IRA, policymakers intended for the Biosimilar Special Rule to exempt products from negotiation with biosimilars. Several biosimilars for Stelara are formally set to launch in 2025 and should able to meaningfully compete in a free market system. CMS should follow the intent of the IRA and immediately remove Stelara from the list. CMS should adjust its guidance so that patients can have access to lower-cost biosimilars for Stelara.

“The Biosimilars Forum and our member companies look forward to continued collaboration with regulators in the Biden Administration and on both sides of the aisle in Congress to help patients access lower-cost biosimilars and lower the cost of prescription drugs.”

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit here.

Related Topics

Related Articles