FDA Approves Sixth Ustekinumab Biosimilar, Yesintek

This article was originally published by The Center for Biosimilars^®.

The approval of Yesintek (ustekinumab-kfce), the sixth biosimilar to reference Stelara, will be used to treat patients with various immunology conditions, including psoriatic arthritis and inflammatory bowel disease. | Image Credit: syahrir - stock.adobe.com

The FDA has approved Yesintek (ustekinumab-kfce), the sixth biosimilar to reference Stelara (ustekinumab) for patients with inflammatory bowel disease (IBD), plaque psoriasis, and psoriatic arthritis.¹

Biocon Biologics, based in Karnataka, India, developed the biosimilar and it is predicted to launch in the second half of 2025, along with Otulfi (ustekinumab-aauz), Selarsdi (ustekinumab-aekn), Imuldosa (ustekinumab-srlf), and Pyzchiva (ustekinumab-ttwe). Wezlana (ustekinumab-auub), the first Stelara biosimilar to receive approval, will launch this January 2025 following a legal settlement with Johnson & Johnson, the manufacturers of Stelara.²

Imuldosa was approved in October 2024,³ Otulfi was approved in September 2024, Pyzchiva was approved in July 2024, and Wezlana was approved in October 2023.⁴

The US prevalence of psoriatic arthritis ranges from 6 per 100,000 to 25 per 100,000, according to the National Institute of Health.⁵ Medscape estimates that between 1% to 2% of the US population has plaque psoriasis.⁶ Additionally, IBD affects 2.4 million to 3.1 million people in the US, contributing to increased prevalence and health care costs.⁷ The CDC reported IBD costs in 2018 reached a total of $8.5 billion annually.

Biocon Biologics shared clinical trial results on Yesintek at the European Academy of Dermatology and Venereology (EADV) 2024 Congress. Research included a phase 3 randomized, double-blind, multicenter study and evaluated the biosimilar against the reference biologic in 384 adult patients with moderate to severe chronic plaque psoriasis.⁸

The primary efficacy endpoint measured the percentage change from baseline in Psoriasis Area and Severity Index. After 28 weeks, the primary endpoint demonstrated equivalence between Yesintek and Stelara. The study also confirmed comparable safety, immunogenicity, and pharmacokinetics profiles.

“This pivotal trial of [Yesintek] clearly met the safety and efficacy endpoints, thereby fulfilling the expectations set for a biosimilar. [Yesintek] offers tangible promise for all patients qualifying for treatment with Ustekinumab,” said Uwe Gudat, MD, chief medical officer, Biocon Biologics, in a statement about the trial.

References

1. U.S. FDA approves Biocon Biologics’ Yesintek, Bmab 1200 biosimilar to J&J’s Stelara (Ustekinumab). Press release. Biocon Biologics; December 1, 2024. Accessed December 2, 2024. https://www.bioconbiologics.com/u-s-fda-approves-biocon-biologics-yesintek-bmab-1200-biosimilar-to-jjs-stelara-ustekinumab/

2. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J.The Center for Biosimilars®. May 29, 2024. Accessed December 2, 2024. https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

3. Jeremias S. FDA Approves Imuldosa, a Biosimilar to Stelara. The Center for Biosimilars. October 11, 2024. Accessed December 2, 2024. https://www.centerforbiosimilars.com/view/fda-approves-imuldosa-a-biosimilar-to-stelara

4. Biosimilar approvals. The Center for Biosimilars. Updated December 2, 2024. Accessed December 2, 2024. https://www.centerforbiosimilars.com/view/fda-approves-imuldosa-a-biosimilar-to-stelara

5. Karmacharya P, Crowson CS, Bekele D, et al. The epidemiology of psoriatic arthritis over 5 decades: a population-based study. Arthritis Rheumatol. 2022;73(10):1878-1885. doi:10.1002/art.41741

6. Lui H, Mamelak AJ. Plaque psoriasis. Medscape. Updated December 21, 2023. Accessed December 2, 2024. https://emedicine.medscape.com/article/1108072-overview#:~:text=Plaque%20psoriasis%20occurs%20worldwide%2C%20although,the%20population%20has%20plaque%20psoriasis

7. IBD facts and stats. CDC. June 21, 2024. Accessed December 2, 2024. https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html

8. Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024. September 25, 2024. Accessed December 2, 2024. https://www.biocon.com/biocon-biologics-announces-new-dermatology-data-to-be-presented-at-eadv-congress-2024/