How the Biosimilars Access and Affordability Act Redefines IRA Delays

Congress is again weighing changes to how the Inflation Reduction Act (IRA) treats biologics facing imminent biosimilar competition. The Biosimilars Access and Affordability Act (H.R. 10628/S. 5571), reintroduced in both the House and Senate, would create clearer criteria for delaying Medicare price negotiation of a reference biologic when a biosimilar is expected to reach the market while keeping the IRA's 2-year maximum delay.¹ Under the bill, manufacturers would certify their expected launch information, and if the biosimilar is not licensed and marketed within the 2-year period, the reference biologic would enter negotiation, and its manufacturer would owe rebates covering the delayed years.¹

In an interview with The Center for Biosimilars^® (CFB), Juliana Reed, MS, executive director of the Biosimilars Forum, discussed how the bill would define "high likelihood," why the current uncertainty is weighing on biosimilar development decisions, and how competition from the Stelara (ustekinumab) biosimilars compares with Medicare's negotiated price.

Juliana M. Reed is the executive director of the Biosimilars Forum. | Image credit: @BiosimilarsForum.jpeg

This transcript was lightly edited for clarity.

CFB: The Biosimilars Access and Affordability Act would have CMS automatically delay a reference biologic's selection for Medicare price negotiation when a biosimilar launch is likely, instead of requiring the biosimilar maker to request it. Why isn't the current process under the IRA's "high likelihood" rule working as Congress intended?

Reed: That is exactly the question, and that is exactly what this legislation will do. It defines high likelihood, and it removes any vagueness. It provides specific requirements about the proof of high likelihood that will grant the delay. Let me go through that. With the automatic delay, the number one thing for the biosimilar developer, in how this bill is written, is that they go to market. It's also the number one thing for the brand drug not to get negotiated under the IRA, which we all expect will expand away from MFPs [maximum fair prices] more toward MFNs; Most Favored Nation negotiation will expand, either with this Congress or the next one. But the biggest and most important thing for the biosimilar developer—and again, going back to the brand—is that the biosimilar launches. What this bill does is allow anyone to request the delay. That's important because not every biosimilar developer knows about what's happening in Washington, DC; perhaps they are not aware of the need to request. So this does allow the brand to request.

The biggest piece, though, is that the biosimilar developer controls the requirement that we will provide an attestation or a certification to CMS that says we will be launching with certainty at the end of the 2-year delay. That is the control the biosimilar developer has in this process. That also gives CMS surety that if they remove the brand drug from the negotiation list, the biosimilar will be launching, because we have to have that attestation in hand.

What does the attestation mean? It means the brand drug has to remove any barriers to our launch. We have to get approved. We provide that attestation, and we should be able to do that with provisional determinations and other things that are coming from the FDA under BsUFA IV [the fourth reauthorization of the Biosimilar User Fee Act]. The other piece, though, is we have to provide the attestation of launch; that is a significant change and a significant requirement. The brand has to remove any IP [intellectual property] that is standing in our way. They have to settle patents. They have to resolve those things, and that is what we will attest to. Without that IP solution, without those settlements, we will not have that attestation. We cannot provide it to CMS that says we launch. So that's the big thing about the automatic delay: the attestation.

CFB: Developing a biosimilar can take up to 9 years and cost up to $300 million, and those decisions are made long before a reference product could be chosen for negotiation. How is the current uncertainty affecting manufacturers' decisions about which biosimilars to develop? Are programs being shelved?

Reed: Absolutely. There are 2 things that a biosimilar developer needs. One, you mentioned the $300 million and 9 to 10 years. That is a very important thing, and we're excited about legislation going through and how the FDA is changing. As an industry, we've proven the science with the FDA, so we are seeing today that clinical efficacy studies are not a requirement for a biosimilar to have for FDA approval. That's because we took the time to prove the science of a biosimilar. They're safe. They're effective. We have over 300 billion patient days over the last 10 years, and the analytics—the science—are advanced. So that's a key piece, and that should decrease that $300 million cost. So that's helpful.

The second most important piece now is the market. The market has to work. The future market, 10 years from now, has to be stable, and that's where the IRA special rule comes in. We need to see that the market has not eroded or that we have the ability to prevent the market erosion and prevent the negotiation from happening 10 years out. That's why this bill is so important: It sets the table for everyone to come together and say, "We want competition; we don't want negotiation." Through the attestation process, we will also now get the IP settled and those barriers removed, and we will have a stable market to launch in. Those are the 2 key factors in biosimilar development, and again, why we need this very clear definition of high likelihood.

CFB: Some may argue that an automatic 2-year delay postpones Medicare savings from negotiation. How do you respond, and how does the bill protect Medicare if a biosimilar doesn't launch on time?

Reed: Thanks, Sabrina. Here's the thing about the 2-year delay. The automatic part is really important because it takes out any subjectivity of anybody at CMS who would be making these decisions in the future. We take out the subjectivity because we have to have the attestation.

The big piece about the 2-year delay is that it's really only a 1-year delay. The reference product could be put on the CMS negotiation list at year 11, and that is when anyone would request a delay. A biosimilar cannot be approved by the FDA until year 12, so that automatically is the first year of this delay. It's really not a delay; it allows the biosimilar to be approved because the FDA can't do it until year 12. Then the 1 year of the delay—and that's all it really is, a 1-year delay—allows the biosimilar to launch, and the reference product is required to give us the ability to provide that attestation.

Now, we've heard from several people who believe negotiation works better than competition. It actually doesn't, and the Stelara biosimilars are a good example. The biosimilars for Stelara launched at 80% to 90% discounts a year before the CMS-negotiated price took effect. A year later, the CMS negotiated price was only 60% [66%].² So actual competition works, because that's what free market competition does. Especially as we all talk about affordability, we'll get a lot more success for what is 2%. Two percent of all the prescriptions in America are for biologics, and they cover 40% of all the Medicare costs. We're going to get a lot more cost savings with competition. The small molecule generic market is the best example of that, and we're the second generation. So it's a 1-year delay, and we have to launch.

References

1. New biosimilar legislation addresses Inflation Reduction Act delay provision. Polsinelli. October 8, 2026. Accessed November 3, 2026. https://www.polsinelli.com/publications/new-biosimilar-legislation-addresses-inflation-reduction-act-delay-provision

2. Jeremias S. CMS announces new drug prices under the IRA, including for Stelara and Enbrel. The Center for Biosimilars. August 19, 2024. Accessed November 3, 2026. https://www.centerforbiosimilars.com/view/cms-announces-new-drug-prices-under-the-ira-including-for-stelara-and-enbrel