Teva, Alvotech secure FDA approval for Stelara biosimilar with early 2025 launch

FDA

Teva, Alvotech secure FDA approval for Stelara biosimilar with early 2025 launch

Published: Apr 18, 2024

By Tristan Manalac

BioSpace

The FDA on Tuesday approved Alvotech and Teva Pharmaceuticals’ Selarsdi (astekinumab-aekn), a biosimilar to Johnson & Johnson’s blockbuster immunotherapy Stelara (ustekinumab).

Like its branded reference product, Selarsdi is a subcutaneous injection that can be used to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in pediatric and adult patients. Unlike Stelara, however, Selarsdi is not approved for Crohn’s disease and ulcerative colitis.

Alvotech CEO Robert Wessman in a statement said that the companies are “delighted” about the approval of Selarsdi, which he insists will provide “a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contributed to the reduction of inflationary pressures in healthcare costs” once it hits the market in early 2025.

The FDA’s approval is based on analytical and clinical data from Teva and Alvotech’s development program, including the Phase III AVT04-GL-301 study which found that Selarsdi was just as effective and safe as Stelara in patients with moderate to severe chronic plaque-type psoriasis. The late-stage trial also found that Selarsdi had an equivalent immunogenicity profile to Stelara.

The partners also submitted Phase I data demonstrating that the pharmacokinetic, safety, immunogenicity and tolerability profiles of the biosimilar was similar to that of the reference product.

Stelara’s active ingredient is ustekinumab, a human monoclonal antibody designed to target and selectively bind the IL-12 and IL-23 cytokines, both of which are important in the inflammatory and immune cascades. Its mechanism of action dampens the underlying pathologic mechanisms in various immune-mediated diseases.

The FDA first approved Stelara in 2009 for moderate-to-severe plaque psoriasis, and the biologic has since become one of J&J’s—and the industry’s—best-selling assets. In 2023, Stelara brought in nearly $10.9 billion, an 11.7% increase from its sales figure the prior year. At the same time, however, Stelara also had to contend with the expiration with one of its key patents.

To stave off the biosimilar competition and to prolong its exclusivity, J&J has been striking a series of deals that would postpone the entry of these competitors in the U.S. market. In May 2023, the pharma reached an agreement with Amgen, which would allow the latter to market its biosimilar no later than January 1, 2025.

Teva and Alvotech signed a similar settlement with J&J, postponing the entry of Selarsdi into the U.S. to no later than February 21, 2025.

Despite the strong performance of its cancer portfolio, J&J on Tuesday reported Stelara sales of $2.45 billion in the first quarter of 2024, falling short of Wall Street expectations of $2.6 billion.

Source: BioSpace