FDA Approves Interchangeability Designation for Teva and Alvotech’s Stelara Biosimilar Selarsdi for Multiple Indications
Selarsdi, a biosimilar to Stelara, is approved for adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.
Image Credit: Adobe Stock Images/Sutipun
The FDA has approved Teva’s and Alvotech’s Selarsdi (ustekinumab-aekn) as a fully interchangeable biosimilar to Stelara (ustekinumab). Selarsdi’s indications include adult and pediatric psoriatic arthritis (PsA) and plaque psoriasis, as well as Crohn disease and ulcerative colitis. The approval covers doses of 45 mg/0.5 mL and 90 mg/mL administered in a single-dose prefilled syringe for subcutaneous injection and 130 mg/26 mL in a single-dose vial for intravenous (IV) infusion.1
"The FDA’s confirmation of full interchangeability for Selarsdi is an important development for patients and providers seeking to expand access to this important treatment," said Thomas Rainey, SVP, US biosimilars, Teva, in a press release. "Teva’s recent launch of two biosimilars—Selarsdi and Epysqli—coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy."
In April 2024, Selarsdi was first approved for patients over six years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for patients over six years of age with active PsA, marking the second Stelara biosimilar to be approved by the FDA.2 In October 2024, the FDA approved an additional presentation for the treatment: a 130 mg/26 mL (5 mg/mL) single-dose vial for IV infusion.3
Amgen’s Wezlana (ustekinumab-auub) was the first Stelara biosimilar to receive FDA approval in October 2023.4
According to the Centers for Disease Control and Prevention (CDC), the prevalence of inflammatory bowel disease (IBD) in the United States ranges between 2.4 million and 3.1 million people, with numbers rising. IBD is most prevalent in non-Hispanic White patients at 0.8%. In both Black and Hispanic populations, prevalence is 0.5%, and in Asian American populations it is 0.4%. Prevalence also increases with age, with those aged over 45 years showing the highest rates.
The CDC has found that individuals with IBD were more likely to have demonstrated unhealthy behaviors in the past. According to CDC data, 26% of adults with IBD had smoked compared to 21% without IBD. Additionally, 38% reported sleeping fewer than seven hours per night, 7% experienced psychological distress, and 50% failed to meet physical activity guidelines.
In 2018, IBD-related costs totaled approximately $8.5 billion, with 71% attributed to prescribed medicines, 18% to inpatient visits, 9% to office-based visits, and 2% to emergency visits.5
According to a study published by the National Center for Biotechnology Information, there were approximately 4.9 million cases of IBD globally in 2019, with the highest number of cases reported in China and the United States.6
“Interchangeability of Selarsdi with Stelara will further enable increased access for US patients to more affordable treatment options and contribute to lowering healthcare costs, which is an important part of our mission as a leading developer and manufacturer of biosimilars globally,” said Anil Okay, chief commercial officer, Alvotech, in the press release. “With two important biosimilars on the US market and Biologics License Applications for three new biosimilar candidates under FDA review, Alvotech continues to rapidly expand its portfolio of high-quality biologics based on a fully integrated approach to development and manufacturing, coupled with a unique focus on biosimilars.”
References
1. Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab). Teva. May 5, 2025. Accessed May 5, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-and-alvotech-announce-fda-approval-of-interchangeability-for-selarsdi-ustekinumab-aekn-with-stela/
2. FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis. PharmExec. April 17, 2024. Accessed May 5, 2025. https://www.pharmexec.com/view/fda-approves-stelara-biosimilar-selarsdi-to-treat-psoriasis-psoriatic-arthritis
3. FDA Expands Indication of Alvotech and Teva’s Stelara Biosimilar. PharmExec. October 22, 2024. Accessed May 5, 2025. https://www.pharmexec.com/view/fda-expands-indication-alvotech-teva-stelara-biosimilar
4. FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases. FDA. October 31, 2024. Accessed May 5, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases
5. IBD Facts and Stats. CDC. Accessed May 5, 2025. https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html
6. Global, regional and national burden of inflammatory bowel disease in 204 countries and territories from 1990 to 2019: a systematic analysis based on the Global Burden of Disease Study 2019. PudMed. Accessed May 5, 2025. https://pubmed.ncbi.nlm.nih.gov/36977543/#:~:text=Results:%20In%202019%2C%20there%20were,policy%20makers%20to%20tackle%20IBD.
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