Dong-A ST's Stelara biosimilar approved by FDA

South Korean pharmaceutical company Dong-A ST has received approval from the US Food and Drug Administration (FDA) for Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Johnson & Johnson’s (J&J) therapy Stelara (ustekinumab). The announcement, made on October 11, stated the company’s plans to introduce Imuldosa to the US market, although the exact launch date remains unspecified. Stelara’s original patent expired in September 2023, yet none of the biosimilars have been released to the market, indicating that Imuldosa will contend in a competitive landscape once available.

Among the already approved biosimilars is Amgen’s Wezlana (ustekinumab-auub), which holds the distinction of being the first Stelara biosimilar to receive FDA approval in November 2023. Despite this, Amgen’s version will not hit the market until January 1, 2025, following a patent settlement with J&J. Similarly, Samsung Bioepis’s Pyzchiva (ustekinumab-ttwe) was approved in July 2024 but will not receive its “interchangeable” designation until after Wezlana’s exclusivity period concludes, pushing its market launch to February 2025.

Other Stelara biosimilars that have received approval include Selarsdi (ustekinumab-aekn) by Alvotech and Teva Pharmaceuticals, and Otulfi (ustekinumab-aauz) by Fresenius Kabi and Formycon. Otulfi, approved earlier this month, is anticipated to reach the market a month after Wezlana.

The expiration of Stelara’s patent in 2023 is expected to diminish its sales. According to GlobalData’s consensus forecasts, the total sales of Stelara are projected to decline steadily, dropping from $10.9 billion in 2023 to $10 billion in 2024, $7.1 billion in 2025, and $5.2 billion in 2026. Stelara, a human IgG1 kappa monoclonal antibody, binds specifically and with high affinity to the IL-12 subunit beta utilized by the interleukin (IL)-12 and IL-23 cytokines, which are associated with inflammatory processes. It is indicated for patients with active psoriatic arthritis, moderate to severe Crohn’s disease, plaque psoriasis, and active ulcerative colitis.

Further Stelara biosimilars are under development, including Accord BioPharma’s DMB-3115, Celltrion’s CT-P43, and Biocon’s BMAB-1200. In February 2024, Rani Therapeutics reported successful top-line data from its Phase I study (NCT05890118) of RT-111, a non-injectable Stelara biosimilar containing CT-P43.

Stelara’s declining sales are a direct result of the competition from these biosimilars entering the market. This competitive pressure is expected to significantly impact Stelara’s market share and revenue in the coming years. As the biosimilar market becomes more crowded, companies like Dong-A ST, Amgen, and Samsung Bioepis will play pivotal roles in shaping the landscape of treatments for conditions such as psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.