South Korea-based Dong-A ST has received a US Food and Drug Administration (FDA) approval for Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar that references Johnson & Johnson’s (J&J) blockbuster therapy Stelara (ustekinumab).
As per an 11 October press announcement, the company will launch Imuldosa in the US. However, it did not specify the product’s launch date. Under the terms of a 2021 global licensing agreement with Intas Pharmaceuticals, Accord Biopharma, a subsidiary of Intas, is set to commercialize Imuldosa.
While Stelara’s composition of matter patent expired in September 2023, none of the approved biosimilars have been launched yet, and Imuldosa will face an increasingly crowded biosimilar market when it can be made available.
The list of already approved biosimilars includes Amgen’s interchangeable biosimilar Wezlana (ustekinumab-auub), which became the first approved Stelara biosimilar when it gained FDA approval in November 2023. However, Amgen’s copycat therapy will not enter the market until 1 January 2025 after settling a patent lawsuit with J&J.
Similarly, Samsung Bioepis’s Pyzchiva (ustekinumab-ttwe), another interchangeable biosimilar, which gained approval in July 2024, will not gain its “interchangeable” designation until the exclusivity period for Wezlana ends, and will be launched in February 2025.
Additional approved biosimilars include Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) and Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz). The latter became the fourth approved biosimilar earlier this month and is expected to launch on the market a month after Wezlana.
In accordance with the 2023 patent expiry, which tends to weaken sales of a brand name product, GlobalData’s consensus forecasts project a steady drop in the total sales of Stelara starting in 2024. While Stelara generated $10.9bn in sales in 2023 in a market without any biosimilars, the forecast predicts Stelara’s revenue to slip to $10bn in 2024, $7.1bn in 2025, and $5.2bn in 2026. GlobalData is the parent company of Pharmaceutical Technology.
Stelara is a human IgG1 kappa monoclonal antibody designed to bind with high affinity and specificity to the IL-12 subunit beta used by the interleukin (IL)-12 and IL-23 cytokines, which are implicated to play a role in inflammation. Stelara is indicated for use in patients with active psoriatic arthritis as well as moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis.
Other Stelara biosimilars in development include Accord BioPharma’s DMB-3115, Celltrion’s CT-P43, and Biocon’s BMAB-1200. Earlier in February 2024, Rani Therapeutics announced positive topline data from its Phase I study (NCT05890118) of RT-111, a non-injectable Stelara biosimilar version that contains CT-P43.
This article was updated to include the Accord’s role in commercializing Imuldosa.
