Amgen’s Stelara Biosimilar Delayed Until 2025 After Settling With J&J

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.