Ustekinumab biosimilar approved to treat moderate to severe plaque psoriasis
The biosimilar to ustekinumab is approved for patients 6 years and up, and is expected to be marketed on or after February 21, 2025.
Ustekinumab biosimilar approved to treat moderate to severe plaque psoriasis | Image Credit: © Calin - © Calin - stock.adobe.com.
Ustekinumab-aekn (SELARSDI; Alvotech and Teva Pharmaceuticals) has been approved by the FDA as a biosimilar to ustekinumab (Stelara; Johnson & Johnson) to treat moderate to severe plaque psoriasis, as well as active psoriatic arthritis, in adults and pediatric patients aged 6 years and up.1
The reference product, a monoclonal antibody, selectively targets the p40 protein. The protein is an aspect of interleukin (IL)-12 and IL-23 cytokines, which play a critical role in the treatment of immune-mediated diseases such as psoriasis and psoriatic arthritis.1,2
The approval of the biosimilar was based on multiple data points, including the phase 3, randomized, double-blind, multicenter, and 52-week AVT04-GL-301 trial (NCT04930042) and the phase 1, randomized, double-blind, single-dose, parallel-group AVT04-GL-101 (NCT04744363).1,3
The AVT04-GL-301 trial sought to demonstrate equivalent efficacy and compare safety and immunogenicity between the reference product and ustekinumab-aekn in 581 patients aged 18 to 75 years with moderate to severe chronic plaque-type psoriasis. The AVT04-GL-301 phase 1 trial was conducted in New Zealand and Australia, enrolling 294 healthy adult volunteers.1
Alvotech and Teva announced in June of 2023 they reached a settlement and license agreement with Johnson & Johnson, granting a license entry date for ustekinumab-aekn in the United States no later than February 21, 2025.1
Ustekinumab-aekn availability will “create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients,” the companies stated in a press release. Plaque psoriasis is the most common form of psoriasis, while psoriatic arthritis makes up approximately 6% of all cases of juvenile arthritis.1
“Bringing SELARSDI to market in the U.S. early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” stated Robert Wiseman, chairman and CEO, Alvotech.1
“The development of SELARSDI leveraged our purpose-built end-to-end development and manufacturing platform for biosimilars. Being able to develop the biosimilar in the same cell type and continuous perfusion process as was used for the reference product, facilitated the development program’s success,” added Wiseman.1
References:
1. Alvotech and Teva announce US FDA approval of SELARSDI (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab). Teva Pharmaceuticals. Press release. April 16, 2024. Accessed April 23, 2024. https://www.tevapharm.com/news-and-media/latest-news/alvotech-and-teva-announce-u.s.-fda-approval-of-selarsdi-ustekinumab-aekn-biosimilar-to-stelara-ust/
2. Efficacy, safety, and immunogenicity of AVT04 with moderate-to-severe chronic plaque psoriasis. ClinicalTrials.gov. Updated February 2, 2023. Accessed April 23, 2024. https://clinicaltrials.gov/study/NCT04930042
3. Pharmacokinetics, safety and tolerability study of AVT04 to EU approved and US licensed Stelara (ustekinumab). ClinicalTrials.gov. Updated May 23, 2022. Accessed April 23, 2024. https://clinicaltrials.gov/study/NCT04744363
3. Pharmacokinetics, safety and tolerability study of AVT04 to EU approved and US licensed Stelara (ustekinumab). ClinicalTrials.gov. Updated May 23, 2022. Accessed April 23, 2024. https://clinicaltrials.gov/study/NCT04744363
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