Alvotech, after J&J settlements, readies Stelara biosim launches in several countries

In the U.S., Alvotech’s biosimilar to Johnson & Johnson's blockbuster immunology drug Stelara is set to face market competition from the likes of Amgen, Sandoz and Fresenius Kabi. But elsewhere, Alvotech hopes to stand out with a series of settlements that will enable it to get a jump on the competition.

Thursday, Alvotech touted settlements with J&J that will allow the biosimilar specialist to launch its Stelara copycat, dubbed AVT04, in Japan, Canada and the European Economic Area this year. The biosimilar has already been approved by the regulatory authorities in these areas, Alvotech said in a release.

“We look forward to working with our commercial partners in launching the first biosimilar to Stelara in these global markets, thereby increasing patient access to a vital biologic,” Alvotech CEO Robert Wessman said in a statement.

Canada is set to get AVT04 first with an expected market entry date during the first quarter of this year, Alvotech said. After that, Alvotech plans to introduce the med in Japan after a round of national reimbursement listings in May.

As for Europe, the company looks to introduce its biosimilar to the first European markets “as soon as possible” following Stelara’s European supplementary protection certificate (SPC) expiration in late July, the company said. SPCs are intellectual property rights that act as extensions to patents in Europe.

In the U.S., Alvotech and its partner Teva are cleared to launch the biosimilar no later than Feb. 21, 2025, a settlement with J&J stipulates. The FDA is slated to decide on the biosimilar's potential approval by April 16 of this year.

Alvotech has run into troubles at its Reykjavik, Iceland, manufacturing facility recently, but the company maintains that it’s in still in a good spot for the FDA approval. The company’s Teva-partnered Humira biosimilar has been rejected several times due to issues at the plant.

Amgen’s Stelara biosimilar, meanwhile, will get the first stab at the U.S. market no later than Jan. 1, 2025, thanks to that company's J&J settlement. Besides Amgen, J&J has inked a series of Stelara patent settlements that will allow staggered market entries in the early months of next year.