“Today’s announcement by CMS only underscores the folly of this government pricing system. CMS is projecting average savings of 22% on these select branded drugs, a number that pales in comparison to the typical savings on generics and biosimilars,” said David Gaugh, interim president and CEO of AAM. “The data is clear: generic-biosimilar competition is the best way to provide patients and taxpayers with affordable medicines. The uncertainty created by the IRA harms generic-biosimilar competition. We urge policymakers to address patent thickets, PBM branded drug rebates, and other root causes that delay generic-biosimilar competition rather than doubling down on government pricing.”

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement reiterating the AAM’s concerns:

“The Biosimilars Forum is very concerned that the Centers for Medicare & Medicaid Services is misinterpreting the Inflation Reduction Act’s biosimilar special provision. Congress’s intent was to exclude from negotiations products that will immediately compete with biosimilars, which would ultimately provide patients with more choice and lower prescription drug prices. The Forum urges CMS to immediately adjust its draft policy to align with Congress’ intent for the law, which will preserve free market competition and lower prices for patients.

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

(Read more: Challenges remain, but generic manufacturers see a bright future with biosimilars)

“When Congress passed the IRA, policymakers intended the biosimilar special rule to exempt products from negotiations involving biosimilars. Several biosimilars to Stelara are The official launch is planned for 2025 and should be able to compete meaningfully in a free market system. CMS should follow the IRA’s intent and delist Stelara immediately. CMS should adjust its guidance so that patients have access to lower-cost biosimilars for Stelara.

“The Biosimilars Forum and our member companies look forward to continuing to work with regulators in the Biden administration and on both sides of Congress to provide patients with access to lower-cost biosimilars and reduce the cost of prescription drugs.”

(Read more: Prioritizing cheaper biosimilar medicines)

For more information on the Biosimilars Forum’s work to improve access to more affordable biosimilars, click here.