FDA Approves Ustekinumab-kfce as Sixth Biosimilar to Stelara

Updated on December 2, 2024, at 11:40 am.

The FDA approved ustekinumab-kfce (Yesintek; Biocon Biologics) as a biosimilar product to ustekinumab (Stelara; Janssen Biotech Inc). The biosimilar is approved for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.¹

FDA Approval, Ustekinumab, Stelera, Crohn disease, Plaque Psoriasis, Psoriatic Arthritis | Image Credit: © Araki Illustrations | stock.adobe.com

According to the settlement and licensing agreement, the commercialization of ustekinumab-kfce is set for no later than February 22, 2024. Ustekinumab helps to manage and treat inflammatory conditions by mediating T-cell response and regulating interleukin (IL)-12 and IL-23. IL-12 and IL-23 are cytokines that control lymphocyte function, according to the National Library of Medicine. Adverse events include nasopharyngitis, headache, fatigue, injection site erythema, bronchitis and upper respiratory tract infection, sinusitis, abdominal pain, fever, and diarrhea.^1,2

In October, there were 3 ustekinumab biosimilar approvals: ustekinumab-aauz (Otulfi; Fresenius Kabi), ustekinumab-aekn (Selarsdi; Teva Pharmaceuticals), and ustekinumab-srlf (Imuldosa; Accord BioPharma).^3-5

Ustekinumab-aauz became the third biosimilar for Stelara approved by the FDA, which followed ustekinumab-ttwe (Pyzchiva; Sandoz, Samsung Bioepis), and ustekinumab-auub (Wezlana; Amgen). For ustekinumab-aauz, the results of 2 studies showed that the Psoriasis Area Severity Index 75 (PASI75) score response was 67% for the 45 mg and 66% for the 90 mg formulation compared to 3% for the placebo. For study 2, the score response was 67%, 76%, and 3%.³

For ustekinumab-aekn, investigators compared the pharmacokinetics, safety, tolerability, and immunogenicity for the subcutaneous biosimilar to the United States-licensed and European Union-approved Stelara formulations. Ustekinumab-srlf was approved after a comprehensive clinical trial program that showed that the biosimilar was similar to the reference product for pharmacokinetic characteristics, safety, tolerability, and efficacy.^4,5

Earlier 2024, ustekinumab-ttwe was approved for all indications of Stelara and was assigned biosimilar interchangeability status. The approval showed that the efficacy, safety, and immunogenicity for up to 52 weeks was similar for those continuing with the biosimilar and those who switched from Stelara to ustekinumab-ttwe. The percentage change from baseline was comparable at 95.8% for those continuing on the biosimilar, 94.5% for those continuing on Stelara, and 95.6% for those who switched to the biosimilar at week 52.⁶

Biosimilars are expected to reduce cost by increasing competition for the reference product. Biosimilars can have an average sales price of 50% less than the reference product at the time of launch. Competition can decrease the average sales price with an average of 25%. In the article, the author states that biosimilar savings from 2021 to 2025 could reach an estimated $38.4 billion.⁷

REFERENCES

1. U.S. FDA Approves Biocon Biologics’ YESINTEK, Bmab 1200 biosimilar to J&J’s Stelara (Ustekinumab). News 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. Colquhoun M, Kemp AK. Ustekinumab. [Updated 2023 Mar 27]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK570645/

3. McGovern G. FDA Approves Imuldosa, Stelara Biosimilar For Treatment of Chronic Inflammatory Conditions. Pharmacy Times. October 15, 2024. Accessed December 2, 2024. https://www.pharmacytimes.com/view/fda-approves-imuldosa-ustekinumab-biosimilar-for-treatment-of-chronic-inflammatory-conditions

4. Gallagher A. FDA Approves Selarsdi as Biosimlar to Stelara in an Intravenous Formulation. Pharmacy Times. October 22, 2024. Accessed December 2, 2024. https://www.pharmacytimes.com/view/fda-approves-selarsdi-as-biosimlar-to-stelara-in-an-intravenous-formulation

5. Gallagher A. FDA Approves Ustekinumab-Aauz as Biosimilar for Stelara. Pharmacy Times. October 1, 2024. Accessed December 2, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-aauz-as-biosimlar-for-stelara

6. Gallagher A. FDA Approves Ustekinumab-ttwe as Biosimilar to Stelara. Pharmacy Times. July 1, 2024. Accessed December 2, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-ttwe-as-biosimilar-to-stelara

7. Szczotka A. Navigating the Rapid Growth of Specialty Drugs: Opportunities, Challenges, and the Path Ahead. Pharmacy Times. September 2, 2024. Accessed December 2, 2024. https://www.pharmacytimes.com/view/navigating-the-rapid-growth-of-specialty-drugs-opportunities-challenges-and-the-path-ahead