Whereas the biosimilar industry is under intense pressure from competition, government policies, and slow adoption in certain disease states, there is one area that I think is somewhat more positive: profitability at the present ustekinumab biosimilar discounted pricing.
When the adalimumab market opened in January of 2023 discounts off list price increased at a rate not seen outside of the multisource generic marketplace. The Samsung Bioepis Biosimilar Market Report and our own reporting featured discounts up to 92% off the wholesale acquisition cost (WAC) of Humira. This resulted in net prices below $500 for a monthly 40-mg dose. Though this is not nickels, as we’ve seen with small-molecule generics, these prices leave relatively small margins for biosimilar makers. If further price concessions are necessary, the manufacturers have little space within which to maneuver.
The story is slightly different with the introduction of the ustekinumab biosimilars earlier this year. Based on a far higher initial WAC for Stelara ($29,000), discounts of 86% to 90% are offered by several manufacturers, leading to prices of $3,000– $4,200 per 90-mg prefilled syringe. Despite these large ustekinumab biosimilar WAC discounts, the net cost are still well above what payers would consider specialty pharmacy cost thresholds. The result is that the manufacturers should have far greater room for profitability—despite heavy competition—than we have seen on the adalimumab side of the fence.
Of course, it is entirely possible that discounts may increase even further. I have trouble verbalizing a biological product offered at a 95% to 97% WAC discount. It would literally take this sort of decrease to put Stelara biosimilars in the same profitability category as the adalimumab market. One must also assume that the cost to produce ustekinumab biosimilars, once production has begun, will not significantly erode the profit margin.
According to Johnson and Johnson’s second-quarter earnings statement, Stelara net sales dropped 42% in the US compared with the second quarter of 2024. Over the first six months, sales have fallen 37% in the US (roughly an $800 million difference for the quarter and $1.2 billion difference for the year), assumingly because of the initial biosimilar competition. Third- quarter results, which won’t be released until October, maybe even more revealing as several other products will have launched and more formulary decisions for 2026 are announced.
This does not mean of course that the savings extracted by competition is due to biosimilar utilization. We need more evidence to confirm that the early biosimilar marketers are indeed earning revenues themselves on the ustekinumab biosimilar market (Amgen did not release net sales of Wezlana in the US in its own second-quarter results). If this is the case, it lends hope for the many manufacturers participating in this drug category who may see rapid uptake and revenue.
In Other Biosimilar News…
On August 6, Celltrion, Inc. announced it received FDA approval for a new indication for its Avtozma tocilizumab biosimilar: The intravenous (IV) formulation is now approved to treat cytokine-release syndrome in adults and pediatric patients aged 2 years and older. Celltrion reported that Avtozma now has all of the indications for use as the IV reference product Actemra.