Alvotech settles with J&J to launch Stelara biosimilar in Europe, Canada

Reuters
·1 min read
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The company logo for Johnson & Johnson is displayed on a screen to celebrate the 75th anniversary of the company's listing at the NYSE in New York

(Reuters) -Alvotech said on Thursday it has reached settlement agreements with Johnson & Johnson for launching a biosimilar of the pharmaceutical giant's blockbuster psoriasis drug Stelara in Japan, Canada and Europe this year.

The deals allow Alvotech's biosimilar, or near copies of a biological drug, to enter the Canadian market in the first quarter of this year and Japan in May. Entry to the first European markets is expected after late July.

Stelara has been J&J's top-selling drug since 2019, but its key patents began to expire last year.

Alvotech said its marketing partner in Japan, Fuji Pharma, already has authorization for the drug and it will be marketed as Ustekinumab BS (F) in the country, while the biosimilar will be sold by Alvotech's partner JAMP Pharma in Canada.

STADA Arzneimittel will start selling the biosimilar under the name Uzpruvo from July in some countries that are part of the European Economic Area.

In June, Alvotech and its Israeli partner Teva Pharmaceutical reached a settlement and licensing agreement with J&J for the launch of the biosimilar, AVT04, no later than Feb. 21, 2025, if it gets U.S. FDA approval. The regulator's decision is expected by April 16.

A key Stelara patent expired in the United States last year, but J&J struck deals with competitors to delay the launches of their biosimilars until 2025. Amgen will be the first to launch its near-copy, Wezlana, next year.

(Reporting by Leroy Leo in Bengaluru; Editing by Shilpi Majumdar and Shounak Dasgupta)