Biosimilars have never been assured market success. The first oncology and oncology support therapies that were approved as biosimilars gained fairly rapid adoption, however, despite price points that were not always deeply discounted relative to the reference product.
With the publication of Samsung Bioepis’ latest Biosimilar Market Report, covering data through the first quarter of 2025, it is instructive to identify some of the biosimilars that are at highest risk for discontinuation, strategic reevaluation, or possible sale. Although many biosimilar brands in certain categories have lower than 10% uptake, I’m restricting this evaluation to only those biosimilars that have 3% or lower utilization according to the data published in the trend report. The data is based on information from IQVIA. Since several biosimilar drug categories have uptake levels above this threshold, I will not report on each one. In addition, ustekinumab and tocilizumab biosimilars were introduced very recently, and the market penetration data are not yet evaluable in this respect.
Trastuzumab Biosimilars
Starting with the oldest category I’ll discuss, two trastuzumab products have been on the market for several years and are struggling to gain a foothold. These are Herzuma with 1% marketshare and Ontruzant with 3% marketshare. Their listed ASP prices, interestingly, lie at either end of the pricing spectrum. Herzuma has the highest ASP price, matching that of Herceptin the reference product; Ontruzant has the lowest ASP price. Notably, ASP pricing for this category has taken many twists and turns since reaching a floor around the second quarter of 2024. Since then, it has seen something of a rising trend overall.
The reference product Herceptin has seen its marketshare whittled down to 12%, and the three other biosimilar products have uptake levels of at least 25%.
Pegfilgrastim Biosimilars
Over the course of many years, we’ve followed and reported on the pegfilgrastim biosimilar category. This category has been ceaselessly fascinating, as six biosimilar competitors have jockeyed for positioning since the launch of Fulphila in the fourth quarter of 2019. The last pegfilgrastim biosimilar launch was approximately 2 years ago, and three of the six competitors have stunted marketshares, including Stimufend, Fylnetra, and Ziextenzo. This category also demonstrates little stability in ASP pricing. Ziextenzo continues to have the lowest ASP price at $283 per 6-mg dose, after seeing precipitous drops in previous reporting periods.
Fylnetra possesses a very high ASP ($1,751), and Stimufend is 55% higher than this ($2,710). Keep in mind that these data do not include products with on-body injectors and that Neulasta’s price is in the middle of the pack. This reference product retains a 16% marketshare.
Adalimumab Biosimilars
Finally—perhaps unsurprisingly—we come to the adalimumab category. The numbers are a bit more difficult to interpret, because IQVIA does not include the Cordavis biosimilars in their reporting. However, they indicate a 27% biosimilar penetration into this market. Whereas several biosimilars have less than 10% marketshare, Abrilada, Cyltezo, Hulio, Idacio, Yuflyma, and Yusimry are well below my arbitrary 3% threshold. They were commercialized two years ago. Nuvaila’s private-label version of Amgen’s Amjevita, is also at 3% marketshare, and the original Amjevita brand is at 2%.
We assume that all of the manufacturers of these underperforming adalimumab biosimilars are considering their options. Even if three brands were taken off the market completely, it would still leave more than 4 competitors, with low WAC pricing in the area of $500 per 40-mg dose.
Does Low WAC Mean Low Profitability?
This brings me to the final topic of discussion: low WAC pricing in the ustekinumab space relative to the adalimumab category—two immunology biologics with similar indications. Consider that the original list price of reference product Stelara was much higher than that for Humira ($29,000 vs. $3,461, respectively).
At a 90% discount for ustekinumab biosimilars, its $3,000 per 90-mg dose is sixfold higher than that for a 85% WAC discount for adalimumab. As a result, the profit margin for ustekinumab biosimilar manufacturers should not be nearly as tight as that for adalimumab biosimilar makers. Assuming that the production price for ustekinumab is far lower than the low-WAC price, manufacturers may have the ability to take a longer view to market penetration.
In talking with many of my colleagues, it seems reasonable to expect a quicker uptake for Stelara biosimilars than we experienced with competition for Humira. Perhaps the second quarter data to be reported by Samsung Bioepis later this year will confirm our suspicions.
In the meantime, several biosimilars across drug categories have gained excellent uptake over time, and their producers should be congratulated for their courage and fortitude in demonstrating the way forward in obtaining the promised savings through biosimilar competition.
