Adalimumab and ustekinumab biosimilars aren't the only factors that will drive biosimilar adoption and savings through 2023, according to Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.
Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science, made predictions on what will drive biosimilar uptake and savings over the next 5 years using the data from IQVIA's Biosimilars in the United States 2023-2027 report at Access!, the annual meeting of the Association for Accessible Medicines in Orlando, Florida.
The latest IQVIA Biosimilars in the United States report predicted that spending on biosimilars will increase to $129 billion and generate $180 billion in savings over the next 5 years. What are going to be some of the biggest drivers for these numbers going forward?
Kleinrock: Obviously, the biggest drivers in the next few years are adalimumab biosimilars. But there's other products in the same category: ustekinumab (Stelara) biosimilars is coming very soon. There's also some other areas, like age-related macular degeneration. So, ranibizumab and following slight thereafter is aflibercept.
But we have a an outlook with a number of these medicines that we think are going to have a reasonably big impact on the dollars going to the biosimilars, as well as to the savings. We also profile a significant set of uncertainties we feel like in terms of the uptake and the different behavior of individual companies in marketing the biosimilars. How competition has so far worked out in terms of the concentration in the market.
Imagine a circumstance where there's a large number of companies challenging one particular molecule and not all of them make their return. The sustainability of the market for biosimilar makers is a key question, as well as the sustainability if biosimilars are not entering the market or are lower selling than originators. So, a lot of questions that really frame the future of this sector where there are 300 or so molecules that are biologics, and so far, we have 39 of them with approvals or are in the pipeline, and many more that have not yet begun that journey; it's unclear how many will.
The report focused a bit on the US market introduction of up to 10 adalimumab biosimilars, including Amjevita, which just launched at the end of January 2023. How do you anticipate this portion of the biosimilars market developing through 2027 and what are going to be the main factors driving utilization trends for these products?
Kleinrock: The thing that we include in a couple of the exhibits in the report is is an assessment of the adalimumab market for a couple of key dynamics.
One, you mentioned, is the number of challengers, but the other is the nature of the originator. Subsequent to the original launch of adalimumab, there have subsequently been reformulations, with a high-potency and citrate-free formulation and a significant migration of the current patients to this newer formulation. Not all of the biosimilars are formulated the same way. There is a difference in the administration a patient would experience and perhaps those benefits are valuable to patients and providers.
So, there's definitely a question of essentially as an analog, when we think about what adalimumab is doing in terms of continuing to move that innovator forward, how that has played out in other molecules when we see that in filgrastim and pegfilgrastim. When we see that in the breast cancer market with trastuzumab and other related products from the originators [Herceptin]. The relevant market of the originator that the biosimilar is similar to may not be the same when we get our biosimilars to the market as it was when the development program started.
Understanding how that market is going to evolve and whether the value of subsequent innovations is telling, or whether the cost savings is the telling feature, all of those are influenced by the negotiating power of the different participants. The more challengers there are, the more game theory comes into play and the more nuanced and generally the deeper the price erosion and volume erosion tends to be.
Fewer competitors tends to result in lower price discounting as well. And those are patterns that we've seen go back to small molecules and back to the beginning of the Hatch Waxman Act. So, we should expect to see many those things come out. But it's going to be interesting to see what the participants do.
Probably my key observation on this is the way in which the originators participate in these markets. We've seen a mix. Historically, we've seen originators essentially exit—not lower their price post expiry, not compete on price with the biosimilars essentially. We've also seen them lower their price and essentially compete for the volume and the contracts after the presence of biosimilars.
Those will have an effect, and there is a scenario you can imagine where this system, society as a whole, saves money because of the presence of biosimilars but the biosimilar maker isn't rewarded for it commercially. That could be one of the outcomes we see here; it's a lot of money that we're talking about. These are big selling products sometimes. The amount to play for is certainly motivating and that's why you're seeing, as you said, as many as 10 competitors, and some of the other products have a similar number.
To dowload the full IQVIA report, click here.