Johnson & Johnson may find a silver lining in the recent FDA approval of Amgen’s biosimilar for Stelara. This approval offers J&J the opportunity to avoid Medicare price negotiations outlined in the Inflation Reduction Act (IRA), set to begin in 2026 for a selection of drugs. Under this framework, a therapy could be removed from the negotiation list if a relevant generic or biosimilar enters the market. The Department of Health and Human Services (HHS) noted that Stelara’s biosimilar entry was expected by early 2025 and argued that this would lead to Stelara being deselected from negotiations.
Now, these predictions seem to be materializing as the FDA granted approval to Amgen’s interchangeable biosimilar, Wezlana, on October 31. Wezlana is set to be the first biosimilar challenger to Stelara, with a launch expected around the beginning of 2025, following a settlement between Amgen and J&J.
Also Read: Amgen Secures FDA Approval For Stelara Biosimilar, Awaits 2025 Launch Post-Settlement
For context, in 2022, Stelara generated $9.72 billion in sales across its various indications, making it a significant revenue source for J&J. J&J had also made a similar deal in June with Alvotech and Teva to delay the launch of their biosimilar version until February 21, 2025, pending FDA approval.
Several other companies, including Samsung Bioepis, Celltrion, Biocon, and a partnership between Bio-Thera Solutions and Hikma Pharmaceuticals, are also developing Stelara biosimilars.
Stelara was among the initial drugs slated for negotiations by the Centers for Medicare & Medicaid Services, alongside other pharmaceuticals like J&J’s Imbruvica and Xarelto, Bristol Myers Squibb’s Eliquis, and Merck & Co.’s Januvia. While Stelara biosimilars pose a threat to J&J’s top-line revenues, HHS’ decision to remove it from negotiations would spare the company from a process that has been met with apprehension by top industry players.
It’s worth noting that many drugmakers, trade groups, and even the US Chamber of Commerce have legally challenged the impending price negotiations in response to the IRA. Recently, Novartis, AstraZeneca, and Boehringer Ingelheim joined this legal counteraction, further adding to lawsuits from Merck, BMS, and J&J.
Also Read: AbbVie’s Skyrizi Beats J&J’s Stelara In Crohn’s Disease Showdown
In a September filing, Novartis criticized the negotiation process as a “sham” and criticized the potential tax penalties for uncooperative companies as “draconian” and “wildly disproportionate to the punished conduct.” Meanwhile, Astellas Pharma from Japan withdrew its legal challenge to the IRA in September after its cancer blockbuster Xtandi failed to make the CMS’ price negotiations list.
Despite the industry’s discontent with the pricing provisions of the IRA, all drugmakers included in the 2026 negotiation process have agreed to participate. This development underscores the complexities and debates surrounding pharmaceutical pricing regulations in the United States.
