Ustekinumab Biosimilar Launches in France, Shifts the Autoimmune Disease Market

An ustekinumab biosimilar to Stelara launched in France, completing its rollout across 5 major European markets and paving the way for its US launch. | Image Credit: lazyllama - stock.adobe.com

Celltrion’s Stelara biosimilar ustekinumab-stba (Steqeyma) launched in France, continuing a global push and further intensifying competition in the growing ustekinumab market.¹ The launch completes the drug’s rollout across 5 major European markets: France, Germany, Italy, Spain, and the United Kingdom (UK).

Steqeyma is set to launch in additional European countries in late 2025 ahead of its official launch in the US. It marks the seventh Stelara biosimilar approval in the US and is indicated to treat inflammatory conditions.² The FDA approval in December 2024 was based on phase 3 study results that compared the efficacy and safety of CT-P43 with Stelara in patients with plaque psoriasis (NCT04673786).

Steqeyma was manufactured by Janssen to inhibit interleukin (IL)-12 and IL-23, both linked to inflammation. When ustekinumab binds to p40, it prevents associations of both IL-12 and IL-23 to the IL-12Rb1, leading to immune cell activation.² The drug will be offered as a 45 mg and 90 mg/mL single-dose prefilled syringe for subcutaneous injection and a 130 mg/26 mL single-dose vial for intravenous infusion.

Celltrion’s goal is to gain significant shares of the global ustekinumab market,¹ which is expected to drive the greatest amount of impact in the US in 2025 for patients with autoimmune conditions, based on an IQVIA report.³

By February 2025, Celltrion plans to initiate observational studies in France for ustekinumab-stba.¹ The company aims to utilize targeted marketing strategies to address physicians’ needs while strengthening its position in the French autoimmune disease market. Earlier this month, both Italy and Spain were introduced to ustekinumab-stba. Prior to this launch, Steqeyma launched in both Germany and the Netherlands in November 2024.

Celltrion has implemented strategies that adapt to the unique dynamics of each country’s pharmaceutical market. Recently, Steqeyma launched in the UK following the early invalidation of Janssen’s patent relating to the use of ustekinumab to treat ulcerative colitis. The Justice of England and Wales refused Janssen leave to appeal the decision that the UK counterpart of Janssen’s European Patent No. EP 3883606 is invalid.⁴ The ruling against Janssen’s application was considered a success for Samsung Bioepis. As a result, Celltrion was permitted to secure access for all approved indications for plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

The global ustekinumab market is expected to grow from $11,177.34 million in 2024 to $11,850.79 million in 2025, with a compound annual growth rate (CAGR) of 6%.⁵ Overall market size is assumed to grow up to $14,768.48 million in 2029, with a CAGR of 5.7%.

Anticipated future trends in the adoption of biologic therapies like biosimilar ustekinumab are the development of advanced drug delivery systems, data-driven health care systems, partnerships, licensing agreements between pharmaceutical companies, and advances in biologics manufacturing technologies.

The European rollout and imminent US launch of Steqeyma is poised to significantly impact the treatment landscape for patients with autoimmune diseases by offering a more affordable and accessible alternative to the originator drug.

References

1. Ji-hye K. Celltrion launches Stelara biosimilar in France, completing rollout in Europe ahead of US debut. Korea Biomedical Review. January 23, 2025. Accessed January 23, 2025. https://www.koreabiomed.com/news/articleView.html?idxno=26419
2. Santoro C. FDA approves seventh ustekinumab biosimilar to reference Stelara. AJMC^®. December 20, 2024. Accessed January 24, 2025. https://www.ajmc.com/view/fda-approves-seventh-ustekinumab-biosimilar-to-reference-stelara
3. Global use of medicines 2024: outlook to 2028. IQVIA Institute for Human Data Science. January 16, 2024. Accessed January 24, 2025. www.iqviainstitute.org
4. Janssen refused leave to appeal UK court decision revoking Stelara (ustekinumab) UC patent. Pearce IP. September 26, 2024. Accessed January 24, 2025. https://www.pearceip.law/2024/09/26/janssen-refused-leave-to-appeal-uk-court-decision-revoking-stelara-ustekinumab-uc-patent/
5. The Stelara (ustekinumab) global market report 2025. The Business Research Company. January 2025. Accessed January 24, 2025. https://www.thebusinessresearchcompany.com/report/stelara-ustekinumab-global-market-report-