FDA Approves First Ustekinumab Biosimilar With Interchangeability Designation

The first ustekinumab (Stelara) biosimilar has been approved in the United States, and it was also granted interchangeability status.¹ Wezlana (ustekinumab-auub) from Amgen was approved based on results from a phase 3 trial confirming comparable safety and efficacy of the biosimilar to the reference product. Ustekinumab is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23.

The biosimilar is approved to treat adults or children with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis, and adults with moderately to severely active Crohn disease and moderately to severely active ulcerative colitis.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement.¹ “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Wezlana is the seventh biosimilar in the United States to be deemed interchangeable. The first was Semglee (insulin glargine-yfgn), followed by Cyltezo (adalimumab-adbm), Cimerli (ranibizumab-eqrn), Rezvoglar (insulin glargine-aglr), Byooviz (ranibizumab-runa), and, most recently, Abrilada (adalimumab-afzb).

Interchangeability is a designation that is unique to the United States, and it means companies underwent a switching study between the reference product and the biosimilar. As a result, pharmacies may substitute the reference product for the biosimilar in most states.² In the European Union, any approved biosimilar is considered automatically interchangeable.³

Wezlana’s launch will be delayed until 2025 as the result of a patent lawsuit settlement with Johnson & Johnson, the maker of Stelara.⁴ Although the settlement terms are confidential, Amgen revealed that it could sell the biosimilar “no later than January 1, 2025.”⁵

Stelara is blockbuster drug that launched in 2009 and had sales of more than $9.7 billion in 2022.⁵

The FDA recently declined to approve another ustekinumab biosimilar. Alvotech received a complete response letter (CRL) for its ustekinuamb product, AVT04, due to issues with the FDA’s inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland.⁶ The company had previously received 2 CRLs for its adalimumab product for the same reason.

According to Alvotech, the CRL was expected due to those previous responses, and it expects the FDA to conduct another inspection of the facility at the beginning of 2024.⁷

There are multiple ustekinumab biosimilars in phase 3 trials from Biocon, Celltrion, Formycon, Samsung Bioepis, and others.⁸

References

1. FDA approves interchangeable biosimilar for multiple inflammatory diseases. News release. FDA. October 31, 2023. Accessed November 1, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases

2. Humphreys S. Understanding interchangeable biosimilars at the federal and state levels. Am J Manag Care. 2023;29(7 Spec No.):SP545-SP548. doi:10.37765/ajmc.2023.89419

3. Biosimilar medicines can be interchanged. News release. European Medicines Agency. September 19, 2022. Accessed November 1, 2023. https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged

4. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. The Center for Biosimilars®. May 29, 2023. Accessed November 1, 2023. https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

5. U.S. FDA approves Amgen's biosimilar version of J&J's psoriasis drug. Reuters. October 31, 2023. Accessed November 1, 2023. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-amgens-biosimilar-vesrion-jjs-stelara-2023-10-31/

6. Jeremias S. Eye on pharma: another CRL for Alvotech; Cimerli’s growing market share; BBCIC awarded grant. The Center for Biosimilars. October 19, 2023. Accessed November 1, 2023. https://www.centerforbiosimilars.com/view/eye-on-pharma-another-crl-for-alvotech-cimerli-s-growing-market-share-bbcic-awarded-grant

7. Alvotech provides update on status of U.S. biologics license application for AVT04. News release. Alvotech. October 12, 2023. Accessed November 1, 2023. https://investors.alvotech.com/news-releases/news-release-details/alvotech-provides-update-status-us-biologics-license-application

8. Cardinal Health. New and upcoming biosimilar launches. Updated October 11, 2023. Accessed November 1, 2023. https://www.cardinalhealth.com/content/dam/corp/web/documents/Report/cardinal-health-biosimilar-launches.pdf