FDA approves first ustekinumab biosimilar

FDA approves first ustekinumab biosimilar

FDA headquarters.

  • The FDA granted marketing approval and interchangeability status to Wezlana – first ever biosimilar to ustekinumab.
  • The new biosimilar, developed by Amgen, was approved in all indications of the originator, which include plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Ustekinumab (Stelara®), a blockbuster monoclonal antibody originally developed by Janssen Pharmaceuticals, has just got a biosimilar counterpart. The new biosimilar, Wezlana®, manufactured by Amgen, received FDA approval in all indications of the originator, which include plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The FDA also granted it an interchangeability status, which means that all pharmacies will be allowed to substitute the reference drug for the new biosimilar, without the need for provider’s permission. As of November 16, 2023, Wezlana® is the 7th interchangeable product in the US.

The basis for approval was a Phase III study comparing Amgen’s biosimilar to the US-manufactured reference product in 563 patients with moderate-to-severe psoriasis. Patients receiving the two drugs experienced similar drops in psoriasis area severity index (PASI), with no identified safety or immunogenicity issues. Amgen has also submitted the results of switching study, in which the participants were switched from reference to biosimilar and vice versa. This study provided evidence that such changes have no meaningful impact on clinical outcomes and adverse events.

Ustekinumab, which targets two major cytokines implicated in the autoimmune process, IL-12 and IL-23, is viewed as one of the most effective medications for treating plaque psoriasis and other label conditions. It is estimated that psoriasis alone affects more than 7 million people in the US, making it an incredibly lucrative market for biosimilar developers. In 2022 Stelara® domestic sales reached an astounding value of $6.4 billion, but with the approval of biosimilars it is expected to plunge in the coming years.Unfortunately for Amgen, Wezlana will not appear on pharmacies’ shelves any soon. Its market launch had to be delayed until early 2025, following the settlement of a lawsuit filed by Stelara’s manufacturer, Janssen. This delay may have dire consequences for Amgen, as the race is still on, and many biosimilar candidates are heading for approval on both EU and US markets.

References

  1. FDA News Release “FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases”. October 31, 2023. Link: https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases
  2. Johnson & Johnson 2022 Annual Report. Link: https://www.investor.jnj.com/files/doc_financials/2022/ar/2022-annual-report.pdf
  3. “Amgen settles patent lawsuit over biosimilar of J&J’s big-selling Stelara”. Reuters (May 23, 2023). Link: https://www.reuters.com/business/healthcare-pharmaceuticals/amgen-settles-jj-patent-lawsuit-over-drug-similar-blockbuster-stelara-2023-05-23/