Sandoz and Samsung Bioepis ink commercialization agreement for J&J’s Stelara biosimilar

Another biosimilar hopeful for Johnson & Johnson’s Stelara is taking steps to move to market as patent protections are set to end this year, this time in the form of a commercialization agreement between Sandoz and Samsung Bioepis that was announced today.

Sandoz and Samsung’s biosimilar is one of at least six that are being developed — despite that, Stelara was included on the initial list of drugs that will be subject to price negotiations beginning in 2026 under the Inflation Reduction Act.

SB17, a proposed biosimilar to Stelara (ustekinumab), is Samsung Bioepis’ fourth candidate in its immunology pipeline. Phase I trial results for the biosimilar of SB17 “demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity profiles” between SB17 and Stelara, according to Samsung Bioepis.

More data from a Phase III trial will be out this year, though the company didn’t specify when and financial terms of the deal were not disclosed.

Samsung and Sandoz are not the first or the farthest along in the race to create a biosimilar of the blockbuster drug, which was first approved by the FDA in 2009, originally for moderate to severe plaque psoriasis. Later indications for the dual-targeting IL-12 and IL-23 antibody include Crohn’s disease, psoriatic arthritis (including in children) and ulcerative colitis. Stelara made $9.7 billion in 2022 sales, according to J&J’s annual report.

J&J has attempted to fight NDAs filed for Stelara biosimilars in court, but has reached settlements in the cases with many of the copycats, agreeing to biosimilars entering the market in 2025.

Joaquin Duato

J&J CEO Joaquin Duato said on the pharma giant’s full-year earnings call that the company expected “the erosion curve of Stelara to be slightly steeper than that of Remicade, given the evolution of the biosimilar market and the fact that Stelara is a self-administered product. When we think about Stelara in the US, we see the sales of Stelara flat to declining.”

In May, Amgen and Janssen settled their lawsuit over its Stelara biosimilar. Amgen will be allowed to launch its Stelara biosimilar no later than Jan. 1, 2025.

Earlier this summer, Alvotech and partner Teva agreed to a settlement and license agreement with Johnson & Johnson to bring their Stelara candidate, AVT04, to US consumers by no later than Feb. 21, 2025.

Formycon and Fresenius Kabi, which also have a commercialization agreement, announced a settlement with J&J earlier this month. Their biosimilar candidate to Stelara is set to be launched in the US by April 15, 2025.

Other biotech companies looking to jump on the Stelara train include China’s Bio-Thera Solutions and Australia’s NeuClone, alongside Korean company Celltrion.

J&J had three drugs total on the government’s list of the 10 first drugs to face price negotiations: Stelara, Xarelto and Imbruvica.

The Inflation Reduction Act requires companies to participate in pricing negotiations or else pay a steep tax or risk losing Medicare and Medicaid coverage entirely. The negotiated prices for the 10 therapies will take effect Jan. 1, 2026, according to revised guidance published by CMS.

Stacie Dusetzina, professor of cancer research at Vanderbilt University School of Medicine, previously told Endpoints News that the negotiated price of the drugs might not matter in some cases if biosimilar or generic versions come to market between now and 2026. Dusetzina added that it’s still unclear how CMS sees the threshold of competition that will get the listed drugs out of negotiation.

Drugmakers have already headed to court over drug price negotiations. J&J, Merck and others have already filed suit against the federal government.

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