How Biosimilar Treatment Will Change in 2023 and Beyond

EP: 1.An Overview of Biosimilars and Future Agents

EP: 2.Defining Interchangeable Biosimilars

EP: 3.Looking at Published Data and Implications of Interchangeability

EP: 4.Automatic Substitution With Interchangeable Biosimilars

EP: 5.Biosimilar and Interchangeable Biosimilar Conversion Programs

EP: 6.2023 Biosimilars Landscape

EP: 7.Indications for Adalimumab Biosimilar Therapy

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EP: 8.How Biosimilar Treatment Will Change in 2023 and Beyond

EP: 9.Gaining Confidence With a Switching Study

EP: 10.Patient Engagement Strategies to Increase Biosimilar Uptake

EP: 11.Improving Patient Access to Biosimilars

Atheer Kaddis, PharmD: Considerations will be taken into account for 2023 when biosimilars become available for Humira. This is consistent with the way we look at biosimilars in general, not only for Humira. We will review the list price on the biosimilars. We'll also evaluate the rebates that are being offered. We will review whether the biosimilar has interchangeability or not. We will review the FDA-approved indications for the biosimilar, and then we'll also evaluate what our market share shift percentages could be in order to achieve savings over continuing a preferred stance on the reference brand. All of that will be taken into account when we review the biosimilars. That will eventually determine whether we prefer the biosimilars over the reference brand product. We will also review whether there are any incremental rebates that become available on the reference brand; that will also potentially influence our final decision.

Mariam Alboustani, PharmD: For 2023, in the case of branded Humira and the contracting considerations, as we know, a lot of competitors are going to come onto the market. The considerations would be what we've learned along the way and what we've seen from similar products when competitors came to the market, so the expectation is that there is going to be competition rebate-wise. There are going to be more options, and that's good because it drives down the cost of care for everybody involved. We're going to see rebates based maybe on parody positioning of the drugs. We might be surprised and see some rebates based on disadvantaging 1 product instead of 2 products. Without speculating into a lot of details, it is going to be more competitive, and that drives the cost of care down for everybody.

Atheer Kaddis, PharmD: With an interchangeable biosimilar coming to market for a reference brand like Humira, it really improves the chances for market share shift away from the reference brand, which means that we will have much more confidence in adopting a biosimilar strategy with a therapeutically interchangeable biosimilar than if we did not have therapeutic interchangeability. We will see market share shifts away from Humira. That will happen naturally, depending on our review of the financials on the reference brand compared with the biosimilars that will determine what type of stance we take on Humira as our preferred brand name drug today. We have proven over the past several years, from when we started our biosimilar strategy back in 2019, that we are very effective at moving market share to the biosimilars when it makes sense, and we would be prepared to do the same with Humira and other future brand reference products that have biosimilars competition.

Regarding Humira, what we're seeing so far in the market is that all of the biosimilar competition is not going to occur on day 1. There's going to be a ramp-up of biosimilar competition for the brand name product Humira. We may see at least 1 biosimilar that becomes available in early 2023. There will be several more that will become available later in 2023. In 2023, there may be a slow adoption of a biosimilar strategy for Humira, but you may see that ramp up very significantly starting in 2024.

Mariam Alboustani, PharmD: An interchangeable biosimilar in 2023 is going to change the landscape for Humira. First of all, Humira is the number one drug that is being spent on today in the United States. It is on payers' radars, so that is something that they want to tackle. If we want to look at it for the near future, maybe 2023 vs 2024, there are some considerations to take into account. We don't think that the switch is going to be flipped overnight, where Humira is going to be disadvantaged. We're assuming that the biosimilar products are going to be approved sometime in 2023. As we know, for some payers, there are considerations from a formulary perspective, sometimes governed by certain legislative limits. It's not going to be as easy to quickly change that formulary to disadvantage Humira. Again, that is considering that the competitors are going to be at a cost advantage to Humira. Some payers are going to be able to maneuver some disadvantaging but not the majority. What's going to happen through the year is payers are going to be doing some cost modeling. They're going to be looking at other products that are going to be approved on the market and studying the market well. Within that perspective, we can expect a jump in disadvantaging Humira for 2024. The payers have done their studies and had conversations with their provider groups and manufacturers, and they will probably come out in full force in 2024 and come up with these strategies that are going to be clinically equivalent but also cost-effective for them.

It is a good thing that we have these biosimilars and competition coming to the market. It's no surprise to you that in the US health care system, specialty spend is rising. Medical spend is rising. It would be good for patients who will lower their out-of-pocket costs. The more competition we have on the market will be good for both providers and payers.

Transcript edited for clarity.