Johnson & Johnson in deal to allow sales of generics

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 in 2024.

The deals allow Alvotech’s biosimilar, or near copies of a biological drug, to enter the Canadian market in the first quarter of  2024 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 in 2023.

Alvotech said its marketing partner in Japan, Fuji Pharma, already has authorisation 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 February 21, 2025, if it gets approval from the US  Food and Drug Administration. The regulator’s decision is expected by April 16.

A key Stelara patent expired in the US in 2023 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, in 2025.

Reuters