Alvotech (NASDAQ:ALVO) has signed a groundbreaking settlement with Johnson & Johnson (NYSE:JNJ) to introduce biosimilar versions of J&J’s highly successful psoriasis treatment, Stelara, in various international markets.

Plans to Launch in Japan, Canada, and Europe

The Iceland-headquartered pharmaceutical company has firm intentions of rolling out its version of Stelara, named AVT04, in Canada under the moniker Jamteki in the first quarter of 2024 through its partnership with Fuji Pharma JAMP Pharma Group.

In Japan, AVT04 is expected to hit the shelves in May 2024, coinciding with the announcement of the next round of National Health Insurance reimbursement price listings. Moreover, the drug is anticipated to make a swift entry into the European Economic Area immediately following the expiration of Stelara’s intellectual property rights in late July 2024.

Upcoming Launch in the U.S.

Alvotech and its U.S. partner, Teva (TEVA), have reached an agreement with J&J to launch their alternative version by February 2025, subject to regulatory approval. The marketing application for AVT04 is presently undergoing FDA review, with an anticipated action date of April 16, 2024.