FDA accepts BLA for Ustekinumab biosimilar – Alvotech

The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT 04) referencing Stelara, which will be used to treat several autoimmune disorders. Alvotech has a commercialization partnership with Teva Pharmaceuticals, which will have exclusive rights to marketing AVT 04 in the United States if it is approved. The companies anticipate the FDA’s final decision on AVT04 to come in the second half of 2023.

Alvotech reached a settlement agreements with Johnson & Johnson for launching a biosimilar of the its 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 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, AVT 04, no later than February. 21, 2025, if it gets U.S. FDA approval. The regulator’s decision is expected by April 16 2024.