Following Amgen’s January launch of its Stelara biosimilar (Wezlana), at least five other ustekinumab biosimilars have stepped up to the plate, with a licensing dates of February 21 to March 7. Biocon Biologics announced that Yesintek is now available for prescription. Partners Samsung Bioepis and Sandoz launched Pyzchiva. Alvotech and Teva launched Selarsdi on February 21. Formycon AG and Fresenius Kabi also signed a license with Johnson & Johnson, and launched Otulfi on March 4. Celltrion’s Steqeyma was made available on March 13.
That leaves Accord’s Imuldosa, which may launch in May 2025, based on its licensing agreements, as the last of the ustekinumab biosimilars with current FDA approval.
According to a Sandoz spokesperson, Sandoz is launching Pyzchiva at an 80% WAC discount to the list price of the reference product, Stelara. The initial WAC discounts seem to be in the range of 80% to 90%. If the adalimumab experience is any guide, manufacturers will need to be hard at work to obtain private-label agreements with one of the big 3 PBMs to gain any uptake in the short term, despite the steep discounting.
Sandoz told us that the company has entered into a private-label agreement with a PBM to extend the reach of ustekinumab in the US. The specific PBM or terms of the deal could not be disclosed at this time. Sandoz had previously signed the pioneering private-label distribution arrangement for adalimumab with CVS Health’s Cordavis. A further arrangement with Cordavis would thus not be surprising.
| USTEKINUMAB BIOSIMILAR LAUNCH INFORMATION TO DATE | ||||
| Manufacturer/ Marketer | Drug | Launched? | WAC Discount | Private-Label Arrangement? |
| Amgen | Wezlana | Yes | 81% | Yes (Nuvaila) |
| Biocon Biologics | Yesintek | Yes | 90% | Not disclosed |
| Samsung Bioepis/Sandoz | Pyzchiva | Yes | 80% | Yes (Undisclosed PBM) |
| Alvotech/Teva | Selardsi | Yes | 85% | Not disclosed |
| Formycon/ Fresenius Kabi | Otulfi | Yes | Not disclosed | Not disclosed |
| Celltrion | Steqeyma | Yes | 85% | Not disclosed |
| Intas/Accord Biopharma | Imuldosa | May 15 | — | — |
*Information collated from company statements, press releases, and previous reports.
Joshua Salsi, Head of North America, Biocon Biologics, stated in an Email, “Our WAC for Yesintek in a 90mg PFS (the dominant SKU) is approximately $3K, reflecting a ~90% discount compared to the originator’s WAC, making it the lowest-priced ustekinumab biosimilar.” He cautioned that “WAC alone does not provide a complete picture of pricing. Net price—factoring in payer rebates, [distributor service agreement] fees, patient services, and other elements—offers a more accurate representation. Considering these factors, we anticipate that the net prices of other biosimilars will fall within a similar range.”
With regard to the possibility of a private-label arrangement, Mr. Salsi was not willing to say. “However, through our negotiations, we are well positioned for commercial success and many payers have shown strong interest in Biocon Biologics’ biosimilar ustekinumab,” he commented. “We have been actively engaged in discussions regarding coverage and are offering the lowest-WAC ustekinumab on the market. We believe our approach creates a roadmap to success and we are seeing commercial agreements follow, including some that are exclusive to the company.”
Evernorth previously announced that it would be launching a private-label biosimilar that was interchangeable. That qualifies only Amgen’s Wezlana or an unbranded version of Stelara. However, Amgen had previously indicated it was launching Wezlana through Nuvaila only.
Likely, a high-WAC version of several ustekinumab biosimilars will be available for those who want them (and a high rebate). Clearly, early exclusion of the reference product from coverage will be key to biosimilar success. Perhaps that, if nothing else, will propel the utilization of ustekinumab biosimilars.
(This post was updated on March 4 and March 13, to reflect the launch of Fresenius Kabi/Formycon’s product as well as Celltrion’s biosimilar.)
