FDA Expands Indication of Alvotech and Teva’s Stelara Biosimilar

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The FDA has approved an additional presentation of Alotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab). According to Teva, the newly approved solution will be 130 mg/26 mL (5 mg/mL) in a single-dose vial for intravenous infusion. The company stated that the approval will support Selardi in aligning its label with the indications of Stelara, including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease.¹

“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,” said Robert Wessman, chairman, CEO, Alvotech, in a press release. “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.”

Back in April, the FDA first approved Selarsdi to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. This marked the second biosimilar of Stelara to be approved by the FDA. In 2023, the companies reached a settlement and license agreement with the manufacturer of the reference biologic, granting a license entry date forFebruary 21, 2025.^2,3

Last month, the FDA approved Fresenius Kabi’s and Formycon’s Stelara biosimilar called Otulfi. According to a joint press release, the approval was based on analytical, pre-clinical, and clinical data demonstrating Otulfi’s comparable efficacy, safety, pharmacokinetics, and immunogenicity to Stelara in patients with moderate to severe plaque psoriasis.^4,5 Earlier this year, the FDA approved Pyzchiva as a biosimilar to Stelara.⁶

In October 2023, Amgen’s Wezlana was the first biosimilar to Stelara to be approved by the FDA for adult patients and pediatric patients over six years of age.⁷

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, MD, director, office of immunology and inflammation, FDA’s Center for Drug Evaluation and Research, in a press release. “Today’s approval could have a meaningful impact for patients managing their disease.”

According to the Centers for Disease Control and Prevention, prevalence of irritable bowel disease (IBD) in the United States ranges from 2.4 million to 3.1 million people, with prevalence and healthcare costs rising annually. In 2018, IBD accounted for $8.5 billion in total healthcare costs. Prevalence also increases as people age, with individuals over 45 years of age demonstrating the highest prevalence.⁸

“We are delighted to announce our second biosimilar approval in the U.S., which is the thirty-eighth approved market for our biosimilar to Stelara globally. Bringing Selarsdi to market in the US 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. 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,” said Robert Wessman, chairman, CEO, Alvotech, in the press release.

References

1. 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). Teva. October 22, 2024. Accessed October 22, 2024. https://www.tevapharm.com/news-and-media/latest-news/alvotech-and-teva-announce-u.s.-fda-approval-of-additional-presentation-of-selarsdi-ustekinumab-aekn-/

2. FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis. PharmExec. April 17, 2024. Accessed October 22, 2024. https://www.pharmexec.com/view/fda-approves-stelara-biosimilar-selarsdi-to-treat-psoriasis-psoriatic-arthritis

3. Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab). Teva. April 16, 2024. Accessed October 22, 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/

4. FDA Approves Fresenius Kabi, Formycon’s Stelara Biosimilar for Multiple Inflammatory Diseases. PharmExec. October 2, 2024. Accessed October 22, 2024. https://www.pharmexec.com/view/fda-approves-fresenius-kabi-formycon-stelara-biosimilar-multiple-inflammatory-diseases

5. Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi™* (ustekinumab-aauz). Fresenius Kabi. September 30, 2024. Accessed October 22, 2024. https://www.fresenius-kabi.com/news/fresenius-kabi-and-formycon-receive-us-fda-approval-for-biosimilar-otulfi

6. FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US. Sandoz. July 1, 2024. Accessed October 21, 2024. https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/

7. FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases. FDA. October 31, 2023. Accessed October 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases

8. IBD Facts and Stats. CDC. Accessed October 22, 2024. https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html#:~:text=U.S.%20prevalence%20of%20inflammatory%20bowel,IBD%20were%20about%20%248.5%20billion.