FDA Approves Starjemza as New Stelara Biosimilar

The FDA has approved Starjemza (ustekinumab-hmny) as a biosimilar to Stelara (ustekinumab) for the treatment of several rheumatic and gastrointestinal conditions.1

Starjemza, developed as part of a license and commercialization agreement between Hikma Pharmaceuticals and Bio-Thera Solutions, is the eighth ustekinumab biosimilar to receive the green light from the FDA, following the approval of Steqeyma (ustekinumab-stba), which was approved in September 2024.2

"Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it," wrote Bill Larkins, PhD, president of Hikma Injectables, in a statement.1

Since February 2025, 6 ustekinumab biosimilars have launched on the US market: Wezlana (ustekinumab-auub), Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Yesintek (ustekinumab-kfce), and Steqeyma.3-5 Some of them have launched exclusively through private label distributors, such as Wezlana, which is only available to plans that use Nuvaila.3 Imuldosa (ustekinumab-srlf) is the only other ustekinumab biosimilar in the launch pipeline.

The approval was based on data from 2 key clinical studies. A phase 1 randomized, double-blind, single-dose, 3-arm study (NCT04371185) compared the pharmacokinetics, safety, and immunogenicity of Starjemza with both US- and EU-sourced Stelara in healthy volunteers.6 Additionally, a phase 3 multicenter, randomized, double-blind study evaluated Starjemza against Stelara in patients with moderate to severe plaque psoriasis.7 These studies demonstrated that Starjemza has comparable efficacy, safety, and immunogenicity to the reference product, supporting its approval as a biosimilar.1

References

1. Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection. Press release. Bio-Thera Solutions; May 27, 2025. Accessed May 27, 2025. https://www.prnewswire.com/news-releases/bio-thera-solutions-and-hikma-pharmaceuticals-announce-fda-approval-of-starjemza-ustekinumab-hmny-injection-a-biosimilar-referencing-stelara-ustekinumab-injection-302465378.html

2. Jeremias S. FDA approves Steqeyma: the seventh Stelara biosimilar. The Center for Biosimilars®. December 18, 2024. Accessed May 27, 2025. https://www.centerforbiosimilars.com/view/fda-approves-steqeyma-the-seventh-stelara-biosimilar

3. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed May 27, 2025. https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us

4. Jeremias S. 3 ustekinumab biosimilars launch on US market. The Center for Biosimilars. February 24, 2025. Accessed March 12, 2025. https://www.centerforbiosimilars.com/view/3-ustekinumab-biosimilars-launch-on-us-market

5. Jeremias S. More ustekinumab biosimilars join US market share fight. The Center for Biosimilars. March 13, 2025. Accessed May 27, 2025. https://www.centerforbiosimilars.com/view/more-ustekinumab-biosimilars-join-us-market-share-fight

6. Wu M, Li X, Yang D, et al. Comparison of pharmacokinetic similarity, immunogenicity, and safety of ustekinumab and BAT2206 in healthy Chinese male subjects in a double-blind, randomized, single-dose, parallel-group phase I trial. BioDrugs. 2022;37(1):89-98. doi:10.1007/s40259-022-00563-5

7. Man X, Zaharieva K, Pulka G, et al. A randomized phase III study to compare efficacy and safety of BAT2206 (proposed ustekinumab biosimilar) with reference ustekinumab in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2025;92(4):724-731. doi:10.1016/j.jaad.2024.10.104