Pending FDA’s OK, Teva and Alvotech can bring their Stelara biosimilar to US market by 2025

Alvotech and partner Teva have now conquered half the hurdle in bringing a Stelara biosimilar to market.

The two companies announced Monday that they agreed to a settlement and license agreement with Johnson & Johnson to bring candidate AVT04 to US consumers by no later than Feb. 21, 2025.

A Janssen representative told Endpoints News in an email on Monday that the terms of the agreement are confidential, adding that the company “will continue to defend the intellectual property associated with our medicines to protect our ability to innovate and develop life-changing therapies for patients.”

The FDA accepted Alvotech and Teva’s BLA filing in January. The two companies said at the time that they expect an FDA decision sometime in the second half of this year.

A May 2022 readout from Alvotech’s Phase III confirmatory trial claimed that it met the primary endpoint, showing “therapeutic equivalence” between Stelara and its candidate, and noted that there was no meaningful safety difference through 28 weeks of study.

Biosimilars for Stelara — which took over the No. 1 spot as J&J’s top-selling drug from Remicade in 2019 — are inching closer to potential approval, thanks to patent protections that are set to end this year.

Joaquin Duato

“We expect the erosion curve of Stelara to be slightly steeper than that of Remicade, given the evolution of the biosimilar market and the fact that Stelara is a self-administered product,” J&J CEO Joaquin Duato said on the pharma giant’s full-year earnings call. “When we think about Stelara in the US, we see the sales of Stelara flat to declining.”

This is also not the first Stelara biosimilar that’s received permission from J&J to move forward. Last month, a lawsuit between Amgen and Janssen ended with a settlement, although details remain unspecified. Amgen told Endpoints at the time that it would be allowed to launch its Stelara biosimilar, known as ABP 654, “no later than January 1, 2025.”

Stelara was first approved by the FDA in 2009, originally for moderate to severe plaque psoriasis. Later indications for the dual-targeting IL-12 and IL-23 antibody include Crohn’s disease, psoriatic arthritis and ulcerative colitis.

Teva and Alvotech did not immediately respond to requests for comment from Endpoints.

Other biotech companies looking to jump on the Stelara train include Germany’s Formycon, China’s Bio-Thera Solutions and Australia’s NeuClone — alongside Korean companies Samsung Bioepis and Celltrion.

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