Alvotech, Teva secure U.S. license date for proposed Stelara biosimilar

Alvotech and Teva have reached a settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab) in the United States.

The settlement grants a license entry date for AVT04 in the United States no later than Feb. 21, 2025.

Stelara is used to treat adults and children six years and older with moderate to severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills); adults and children six years and older with active psoriatic arthritis; adults 18 years and older with moderately to severely active Crohn’s disease; and adults 18 years and older with moderately to severely active ulcerative colitis.

[Read More: Teva rolls out generic Nexavar tablets]

“We are delighted to have secured a U.S. license date for our second biosimilar candidate in the United States and I believe this exemplifies our multi-product approach to biosimilars globally,” said Robert Wessman, chairman and CEO of Alvotech.

[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]

“Biosimilars are a key component of Teva’s short and long-term strategy,” said Sven Dethlefs, executive vice president of North America Commercial at Teva, “Today’s announcement is another step forward in our partnership with Alvotech, who shares our commitment to lower the cost burden of biologics on the healthcare system.”