In late 2024 and early 2025, multiple ustekinumab biosimilars, including Yesintek, Steqeyma, and Otulfi, received regulatory approvals in the US, Europe, Canada, and the UK, expanding treatment options for Crohn’s disease, psoriasis related conditions, and ulcerative colitis.
Ustekinumab biosimilars Yesintek and Steqeyma approved in the US
On 29 November and 17 December 2024, the US Food and Drug Administration (FDA) approved Biocon’s Yesintek (ustekinumab-kfce), and Celltrion’s Steqeyma/CT-P43 (ustekinumab-stba), which are biosimilars referencing Janssen/Johnson & Johnson’s (J&J) Stelara.
Both Yesintek and Steqeyma/CT-P43, monoclonal antibodies, are approved for the treatment of Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Yesintek (ustekinumab-kfce) will be available as a 45 mg/0.5 mL and 90 mg/mL solution for injection in pre-filled syringe, while Steqeyma/CT-P43 (ustekinumab-stba) will be available as a 45 mg/0.5 mL and 90 m/mL solution for subcutaneous injection and 130 mg/26 mL solution for intravenous injection.
The FDA approved Steqeyma based on phase III study results in adults with moderate-to-severe plaque psoriasis, showing no clinically meaningful differences in safety and efficacy compared to the reference product, ustekinumab.
Both Biocon and Celltrion reached settlement and license agreements with Janssen/ J&J to commercialize their biosimilars in the US by late February 2025. Similar agreements are also in place for Amgen and Alvotech/Teva’s ustekinumab biosimilar [1].
Amgen’s Wezlana (ustekinumab-auub) was the first ustekinumab biosimilar approved with interchangeable designation in the US, in October 20243 [2]. By the end of 2024, the FDA had approved seven Stelara biosimilars.
Ustekinumab biosimilar Yesintek approved in Europe
Following the FDA approval of Biocon’s Yesintek, on 12 December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Yesintek for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease.
Yesintek will be available as a 45 mg or 90 mg solution for injection in pre-filled syringe and a 130 mg concentrate for solution for infusion.
Clinical studies showed that the Yesintek has a similar pharmacokinetic, safety, efficacy and immunogenicity profile compared to the originator product.
By the end of December 2024, the EMA had approved nine ustekinumab biosimilars, with Alvotech/Stada’s Uzpruvo being the first ustekinumab biosimilar approved on 5 June 2024 [3].
Ustekinumab biosimilar Otulfi/FYB202 approved in Canada
On 8 January 2025, Health Canada granted a Notice of Compliance (NOC) for Formycon/ Fresenius Kabi’s ustekinumab biosimilar, Otulfi/FYB202. This approval covers both subcutaneous and intravenous formulations for the treatment of adults with moderately to severely active Crohn’s disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis.
In February 2023, Formycon and Fresenius Kabi entered into a global license agreement granting Fresenius Kabi commercialization rights for FYB202 in key global markets, including Canada. In August 2023, they reached a settlement with J&J, allowing FYB202 to be marketed in the US [4], and a confidential settlement agreement was signed in March 2024 regarding the earliest date for commercialization of Otulfi in Canada.
On 15 January 2025, Otulfi/FYB202 received UK’s MHRA approval for both subcutaneous and intravenous formulations to treat serious inflammatory diseases.
Related articles
Uzpruvo/AVT04 biosimilar in profile
FDA approves fifth ustekinumab biosimilar Imuldosa
|
LATIN AMERICAN FORUM
The objective of GaBI’s Latin American Forum is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View the latest headline article: Estudios comparativos de eficacia: ¿dónde estamos ahora? Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO
El objetivo del Foro Latinoamericano de GaBI es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Ver el último artículo de cabecera: Estudios comparativos de eficacia: ¿dónde estamos ahora? !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
|
References
1. GaBI Online - Generics and Biosimilars Initiative. J&J lawsuits settled over ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 21]. Available from: www.gabionline.net/pharma-news/j-j-lawsuits-settled-over-ustekinumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 21]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
3. GaBI Online - Generics and Biosimilars Initiative. EC approval of first ustekinumab biosimilar Uzpruvo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 21]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-first-ustekinumab-biosimilar-uzpruvo
4. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 21]. Available from: www.gabionline.net/pharma-news/fresenius-kabi-and-formycon-reach-agreement-with-j-j-alvotech-and-teva-expand-partnership
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2025 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment