FDA approves first Stelara biosimilar, Wezlana

The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).

FDA approves first Stelara biosimilar, Wezlana

The US Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab).

Wezlana, like Stelara, is approved to treat:

  • Adults and children six years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
  • Patients six years and older with active psoriatic arthritis
  • Adults with moderately to severely active Crohn’s disease
  • Adults with moderately to severely active ulcerative colitis.

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.”

This evidence included comparisons of the products on an analytical level using chemical and biological tests and assays that confirmed similarity in the structural and functional features of Wezlana and Stelara, as well as comparative human pharmacokinetic data, clinical immunogenicity data and other clinical safety and effectiveness data.

Like Stelara, the most serious known side effect of Wezlana is infection.

The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level, without consulting the prescriber.

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Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” commented Nikolay Nikolov, director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.”

Stelara biosimilars in the US market

The first Stelara biosimilars are expected to enter the US market in 2025.

“We do not expect entry of Stelara biosimilars in the United States during 2024,” Joseph Wolk CFO, Johnson & Johnson, stated during the company’s Q3 earnings call on 18 October. However, he did note that Stelara does have a composition of matter patent expiry in mid-2024 in Europe.

US sales of Stelara totalled $6.4 billion in 2022, according to J&J’s financial results.