Ustekinumab Biosimilar Yestintek Launches in the US, Expanding Treatment Access for Chronic Autoimmune Diseases

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Biocon Biologics has officially launched its biosimilar ustekinumab-kfce (Yesintek) in the United States.¹

This sixth biosimilar to ustekinumab (Stelara; Janssen Biotech) is indicated for use in various conditions, including moderate to severe psoriasis, psoriatic arthritis, ulcertivecolitis, and Crohn disease. The drug is available in various presentations, such as pre-filled syringes (45 mg/0.5 mL, 90 mg/mL) and vials (45 mg/0.5 mL, 130 mg/26 mL), mirroring the formulations of its reference product.

The US Food and Drug Administration approved its use in the above indications in December 2024.² The approval of ustekinumab-kfce approval was supported by a pivotal phase 3 study, STELLAR-2, which demonstrated that ustekinumab-kfce is highly similar to Stelara in patients with moderate to severe chronic plaque psoriasis.³

The clinical findings confirmed that there are no meaningful differences in pharmacokinetics, safety, efficacy, or immunogenicity profiles between ustekinumab-kfce and the originator biologic.³

The approval and launch of ustekinumab-kfceoffers patients access to an affordable and effective biosimilar, addressing the ongoing need for more cost-effective treatments for chronic, immune-mediated diseases.⁴

Shreehas Tambe, CEO and managing director of Biocon Biologics, expressed the company's commitment to improving patient outcomes and expanding treatment accessibility through the introduction of ustekinumab-kfce.

"The launch of Yesintek marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars," Tambe said in a news release.¹ "It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar ustekinumabto this patient population."

According to Josh Salsi, head of North America at Biocon Biologics, clinicians can confidently prescribe Yesintek, assured that it maintains comparable pharmacokinetics, safety, and efficacy to the reference product.

"For health care providers, switching to Yesintek offers a seamless treatment experience covering the same indications and dosing options," Salsi said.¹

References

1. Biocon Biologics launches Yesintek (ustekinumab-kfce) biosimilar to Stelara in the United States. News release. February 24, 2025. Accessed February 24, 2025. https://www.bioconbiologics.com/biocon-biologics-launches-yesintek-ustekinumab-kfce-biosimilar-to-stelara-in-the-united-states/
2. US FDA approves Biocon Biologics’ Yesintek, Bmab 1200 biosimilar to J&J’s Stelara (Ustekinumab). Press release. Biocon Biologics; December 1, 2024. Accessed February 24, 2025. https://www.bioconbiologics.com/u-s-fda-approves-biocon-biologics-yesintek-bmab-1200-biosimilar-to-jjs-stelara-ustekinumab/
3. Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024. News release. Biocon Biologics Ltd. September 25, 2024. Accessed February 24, 2025. https://www.biocon.com/biocon-biologics-announces-new-dermatology-data-to-be-presented-at-eadv-congress-2024/
4. Jacobs P, Bissonnette R, Guenther LC. Socioeconomic burden of immune-mediated inflammatory diseases--focusing on work productivity and disability. J Rheumatol Suppl. 2011 Nov;88:55-61. doi: 10.3899/jrheum.110901