FDA Approves Imuldosa, Stelara Biosimilar For Treatment of Chronic Inflammatory Conditions

Updated on October 15, 2024 at 1:20PM.

The FDA has approved Imuldosa (ustekinumab-srlf; Accord BioPharma), a biosimilar to Stelara (ustekinumab; Janssen Biotech), for the treatment of chronic inflammatory conditions such as psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Imuldosa has received approval for all indications its reference product, Stelara, has received, which includes both adult and pediatric patients. Additionally, Imuldosa was initially developed as DMB-3115 (Dong-A Socio Holdings, Meiji Seika Pharma).¹

Image credit: Araki Illustrations | stock.adobe.com

Ustekinumab is a humanized immunoglobulin G1k (IgG1k) monoclonal antibody used to treat psoriatic arthritis, plaque psoriasis, and inflammatory bowel disease, an umbrella term for Crohn disease and ulcerative colitis. IgG1k antibodies bind to the p40 protein subunit utilized by interleukin (IL)-12 and IL-23 cytokines, which are naturally occurring cytokines involved in both inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation.²

The approval of Imuldosa came after a comprehensive clinical development program, which showed that the treatment is similar to its reference product in terms of pharmacokinetic characteristics, as well as safety, tolerability, and efficacy. Additionally, Imuldosa adheres to the current biosimilar guidance established by the FDA. The biosimilar can be an affordable treatment option for patients with chronic inflammatory conditions while providing similar benefits to the current standard of care. It is indicated for adult patients with the following: moderate to severe plaque psoriasis for those who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn disease; and moderately to severe active ulcerative colitis. Additionally, Imuldosa is indicated for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and active psoriatic arthritis.^1,3

Further, this is the fifth FDA approval for an ustekinumab product¹ and it comes shortly after the approval of ustekinumab-aauz (Otulfi; Formycon, Fresenius Kabi) for Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis in September 2024⁴; ustekinumab-ttwe (Pyzchiva; Sandoz, Samsung Bioepis) for severe psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis in July 2024⁵; and ustekinumab-aekn (Selarsdi; Teva Pharmaceuticals, Alvotech) for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric individuals aged 6 years and older in April 2024⁶. Imuldosa is anticipated to launch commercially during the first half of 2025.¹

“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,” said Chrys Kokino, US president of Accord BioPharma, in a news release.¹

The most common adverse events (AEs) associated with ustekinumab products include nasopharyngitis, upper respiratory tract infection, headache, and fatigue for psoriasis; vomiting for Crohn disease, and nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis for Crohn disease maintenance; nasopharyngitis for ulcerative colitis, and nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea for ulcerative colitis maintenance.³

"We're proud to add Imuldosa to our US biosimilar portfolio, which represents an affordable treatment option for patients living with painful inflammatory conditions," said Binish Chudgar, Executive Chairman of the Board, Intas Pharmaceuticals, in the news release.¹

REFERENCES

1. PR Newswire. FDA Approves IMULDOSA® (ustekinumab-srlf), Accord BioPharma's Biosimilar to STELARA® (ustekinumab), for the Treatment of Chronic Inflammatory Conditions. News release. October 14, 2024. Accessed October 15, 2024. https://www.prnewswire.com/in/news-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions-302275065.html

2. Stelara® (USTEKINUMAB) mechanism of action: Plaque psoriasis. STELARA® (ustekinumab). Accessed October 15, 2024. https://www.stelarahcp.com/plaque-psoriasis/mechanism-of-action/

3. BioSpace. FDA Approves IMULDOSA™ (ustekinumab-srlf), Accord BioPharma’s Biosimilar to STELARA® (ustekinumab), for the Treatment of Chronic Inflammatory Conditions. News release. October 15, 2024. Accessed October 15, 2024. https://www.biospace.com/press-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions

4. Formycon. FDA grants approval for Stelara® Biosimilar FYB202/Otulfi™ (ustekinumab-aauz). News release. September 27, 2024. Accessed October 15, 2024. https://www.formycon.com/en/blog/press-release/fda-grants-approval-for-stelara-biosimilar-fyb202-otulfitm-ustekinumab-aauz/

5. Gallagher, A. FDA Approves Ustekinumab-ttwe as Biosimilar to Stelara. Pharmacy Times. July 1, 2024. Accessed October 15, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-ttwe-as-biosimilar-to-stelara

6. Gallagher, A. FDA Approves Ustekinumab Biosimilar to Stelara for Treatment of Plaque Psoriasis. Pharmacy Times. April 17, 2024. Accessed October 15, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-biosimilar-to-stelara-for-treatment-of-plaque-psoriasis