FDA Approves Ustekinumab-Aauz as Biosimilar for Stelara

The FDA has approved ustekinumab-aauz (Otulfi; Fresenius Kabi) as a biosimilar referencing ustekinumab (Stelara; Johnson and Johnson), with indications including Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, which play a rule in the inflammatory and immune responses.¹

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“The FDA approval of Otulfi, Fresenius Kabi’s fourth biosimilar product in the US market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” Sang-Jin Pak, MD, president of biopharma and member of the Fresenius Kabi Management Board, said in a news release.¹

Ustekinumab-aauz is the fourth biosimilar for ustekinumab to be approved by the FDA. The FDA approved ustekinumab-aekn (Selarsdi; Teva Pharmaceuticals, Alvotech) for subcutaneous use as a biosimilar to ustekinumab in April 2024 and ustekinumab-ttwe (Pyzchiva; Sandoz, Samsung Bioepis) in July 2024. The first biosimilar, ustekinumab-auub (Wezlana; Amgen), was approved in October 2023 and has a product launch date of no later than January 1, 2025, according to the Center for Biosimilars.^2-4

The approval was based on an evaluation of a data package that included analytical, pre-clinical, clinical, and manufacturing information of the biosimilar. The data demonstrate the comparable efficacy, safety, pharmacokinetics, and immunogenicity when compared with the reference product.¹

As part of the clinical data package, investigators included data from Ps STUDY 1 and Ps STUDY 2, including a total of 1996 individuals 18 years and older with plaque psoriasis. For study 1, the proportion of individuals who achieved Psoriasis Area Severity Index 75 (PASI75) score response was 67% for 45 mg and 66% for 90 mg compared with 3% for the placebo. In study 2, approximately 67% and 76% achieved PASI75, respectively, compared with 3% for the placebo. In Ps STUDY 3, investigators examined the response in 110 pediatric individuals, finding that 80.6% of individuals had a PASI75 response compared with 10.8% in the placebo group.⁵

Similar improvements were seen for psoriatic arthritis, according to the PsA STUDY 1 and PsA STUDY 2, with 57% and 62% being PASI75 responders in the 45 mg and 90 mg groups, respectively, compared with 11% for the placebo (study 1) and 51%, 56%, and 5%, respectively (study 2).⁵

Data from the CD-1, CD-2, and CD-3 studies were also submitted for Crohn disease, which showed that approximately 34%, 56%, and 53% achieved clinical remission, respectively, compared with the placebo at 21%, 29%, and 36%, respectively. For ulcerative colitis, approximately 19% and 45% achieved clinical remission in UC-1 and UC-2, respectively, compared with the placebo 7% and 26%.⁵

Ustekinumab-aauz will be available in both the subcutaneous and intravenous formulation, according to the news release.¹

REFERENCES

1. Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi (ustekinumab-aauz). News release. Fresenius Kabi. September 30, 2024. Accessed October 1, 2024. https://www.fresenius-kabi.com/news/fresenius-kabi-and-formycon-receive-us-fda-approval-for-biosimilar-otulfi

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

3. Gallagher A. FDA Approves Ustekinumab Biosimilar to Stelara for Treatment of Plaque Psoriasis. Pharmacy Times. April 18, 2024. Accessed October 1, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-biosimilar-to-stelara-for-treatment-of-plaque-psoriasis

4. Jeremias S. FDA Approves First Stelara Biosimilar, Wezlana. The Center for Biosimilars. November 1, 2023. Accessed October 1, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-stelara-biosimilar-wezlana

5. Otulfi. Package Insert. Fresenius Kabi; 2024. Accessed October 1, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf