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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.
Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease
January 18th 2025Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals
January 11th 2025Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.
