FDA Approves Fresenius Kabi, Formycon’s Stelara Biosimilar for Multiple Inflammatory Diseases

Image Credit: Adobe Stock Images/Lila Patel

The FDA has approved Fresenius Kabi’s and Formycon’s Otulfi (ustekinumab-aauz), a biosimilar to Stelara (ustekinumab), for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. According to both companies, 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. This marks Fresnius Kabi’s fourth biosimilar to be approved by the FDA, aligning with its Vision 2026 strategy to expand its presence in the biopharma market.¹

“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 U.S. 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,” said Sang-Jin Pak, president, biopharma, management board member, Fresenius Kabi management board, in a press release.

Earlier this year, the FDA also approved Sandoz’s Pyzchiva, another biosimilar to Stelara, for treating a number of inflammatory bowel diseases (IBD). Intending to launch in February 2025, Sandoz entered into an agreement with Samsung Bioepis last year to develop and commercialize Pyzchiva.²

"Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis. Unfortunately, barriers to care, including costs, often prevent patients from getting the drug they are prescribed. Psoriatic disease is lifelong and chronic, leading to long-term treatment costs. Having more FDA-approved options can help make appropriate healthcare more affordable,” said Leah M. Howard, JD, president, CEO, National Psoriasis Foundation, in a press release.

In April, the FDA also approved Alvotech’s and Teva’s Selarsdi as a biosimilar to Stelara for both adults and pediatric patients over six years of age, both as an injection and for subcutaneous use. This product is also expected to be on the market in February 2025.³

“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 a press release.

According to the Centers for Disease Control and Prevention, IBD prevalence in the United States is estimated between 2.4 and 3.1 million people. Healthcare costs related to IBD have been on the rise, with a total cost of $8.5 million in the United States in 2018. This includes 71% on prescribed medicine, 18% on inpatient visits, 9% on office visits, and 2% on emergency visits. Prevalence increases with age, as people over 45 years of age have been found to have the highest number of IBDs. Further, adults with an IBD are more likely to have had a history of smoking, sleeping fewer than seven hours a day, experiences with serious psychological distress, and less daily exercise.⁴

References

1. Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi™* (ustekinumab-aauz). Fresenius Kabi. September 30, 2024. Accessed October 2, 2024. https://www.fresenius-kabi.com/news/fresenius-kabi-and-formycon-receive-us-fda-approval-for-biosimilar-otulfi 

2. FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US. Sandoz. July 1, 2024. Accessed October 2, 2024. https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/

3. Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab). Teva. April 16, 2024. Accessed October 2, 2024. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Alvotech-and-Teva-Announce-U.S.-FDA-Approval-of-SELARSDI-ustekinumab-aekn-biosimilar-to-Stelara-ustekinumab/default.aspx

4. IBD Facts and Stats. CDC. Accessed October 2, 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.