FDA Approves Ustekinumab (STELARA) Biosimilar for Crohn’s, UC, Psoriasis, PsA

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The FDA has approved an ustekinumab biosimilar, ustekinumab-kfce, developed by Biocon Biologics and marketed under the name YESINTEK.¹

Ustekinumab-kfce is a monoclonal antibody therapy approved for the treatment of Crohn disease (CD), ulcerative colitis (UC), plaque psoriasis (PsO) and psoriatic arthritis (PsA). Biocon previously announced in February 2024 that it had signed a settlement and license agreement with Janssen to commercialize ustekinumab-kfce, also known as Bmab 1200, allowing its launch in February 2025 pending FDA approval.²

“This agreement for a biosimilar Ustekinumab is an important milestone in our company’s commitment to delivering affordable, life-changing biosimilar medicines. It underscores the Company’s steadfast resolution of supporting the well-being of patients impacted by inflammatory diseases and driving positive change within the healthcare industry,” Matthew Erick, Chief Commercial Officer – Advanced Markets, Biocon Biologics, said in a statement.²

Another ustekinumab biosimilar was recently approved in October 2024, Accord Biopharma’s ustekinumab-srlf (IMULDOSA), for the treatment of UC, CD, PsO, and PsA.³ The biosimilar has a planned launch for the first half of 2025.

"For Accord BioPharma, this is another step forward in our efforts to deliver affordable treatments and satisfy patient needs," Chrys Kokino, US president of Accord, said in a statement.³ "The approval of IMULDOSA, our second biosimilar, is evidence of our growing momentum in the industry and our leadership in supporting families with accessible options to address urgent and critical medical conditions."

The same month, Alvotech and Teva’s ustekinumab-aekn (SELARSDI) was approved for an additional presentation, expanding medication’s label to include the treatment of adults with CD and UC to matching reference ustekinumab’s indications as ustekinumab-srlf and ustekinumab-kfce do.⁴ The new presentation is a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

“We welcome this step which is fully in line with our plan to align the SELARSDI label with the indications of the reference product, prior to launch next year,” Robert Wessman, Chairman and CEO of Alvotech said in a statement.⁴ “We are looking forward to the US launch, after very successful launches of the first biosimilar ustekinumab in Canada, Japan and Europe. This demonstrates our commitment to increasing availability and access to ustekinumab, and other biosimilars in our growing pipeline, for patients worldwide.”

Both approvals were enabled by clinical data demonstrating similarity between the biosimilars and reference ustekinumab on pharmacokinetics, efficacy, safety, and tolerability.^3,4

REFERENCES

1. U.S. FDA Approves Biocon Biologics' YESINTEK™, Bmab 1200 Biosimilar to J&J's Stelara® (Ustekinumab). News release. December 2, 2024. Biocon Biologics. https://www.prnewswire.com/news-releases/us-fda-approves-biocon-biologics-yesintek-bmab-1200-biosimilar-to-jjs-stelara-ustekinumab-302319272.html

2. Biocon Biologics Secures US Market Entry Date for Bmab 1200, a Proposed Biosimilar to Stelara®. Biocon Biologics. News release. February 29, 2024. https://www.bioconbiologics.com/biocon-biologics-secures-us-market-entry-date-for-bmab-1200-a-proposed-biosimilar-to-stelara/

3. Accord BioPharma. FDA Approves IMULDOSA® (ustekinumab-srlf), Accord BioPharma's Biosimilar to STELARA® (ustekinumab), for the Treatment of Chronic Inflammatory Conditions. Press release. PR Newswire. Published October 14, 2024. https://prnmedia.prnewswire.com/news-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions-302274563.html

4. Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab). News release. Alvotech. October 22, 2024. https://www.tevausa.com/news-and-media/press-releases/alvotech-and-teva-announce-u.s.-fda-approval-of-additional-presentation-of-selarsdi-ustekinumab-aekn-/