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Amgen’s Stelara Biosimilar Delayed Until 2025 After Settling With J&J
Amgen has settled with Johnson & Johnson (J&J) over the former’s ustekinumab biosimilar referencing Stelara, delaying the projected launch of the candidate from late 2023 to January 2025.
Johnson & Johnson (J&J), the maker of Stelara (ustekinumab), has settled its lawsuit against Amgen over a proposed ustekinumab biosimilar for the treatment of autoimmune conditions.
The settlement terms are confidential, however, Amgen revealed that the results would delay the anticipated launch date of the biosimilar pending FDA approval from later 2023 to “no later than January 1, 2025.”
Ustekinumab products are human monoclonal antibodies that target interleukin (IL)-12 and IL-23 for the treatment of moderate to severe plaque psoriasis, Crohn disease, ulcerative colitis, and psoriatic arthritis.
Other Ustekinumab Biosimilars in the Pipeline
The European Union is currently reviewing an application for an ustekinumab biosimilar developed through a partnership between Alvotech and STADA Arzneimittel. In January 2023, the FDA accepted a biologics license application for the same product. Fresenius Kabi has also partnered with Formycon to develop an ustekinumab biosimilar.
Samsung Bioepis recently published results from a phase 1 study that demonstrated comparable pharmacokinetics and safety of its ustekinumab candidate (SB17) with the originator.
In January 2023, Dong-A ST announced that results of a phase 3 therapeutic equivalence study demonstrated that its ustekinumab biosimilar (DMB-3115) has similar safety and efficacy profiles to Stelara. The study was conducted in 2021 in the United States and 9 other countries, including as Poland, Estonia, and Latvia. The study included 605 participants with moderate to severe chronic plaque psoriasis and evaluated the safety, efficacy, and immunogenicity of DMB-3115 over 52 weeks.
In addition, Rani Therapeutics, a clinical stage biotherapeutics company based in California, announced that it has started the preclinical development process for RT-111, a RaniPill GO capsule using an ustekinumab biosimilar. The RaniPill Go device was created to address the unmet need for oral biologic medications, and Rani Therapeutics claims that the oral delivery platform can administer any drug, including large molecules, such as peptides, proteins, and antibodies.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors
March 11th 2025The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
