With J&J settlement, Samsung Bioepis and Sandoz lock down Stelara biosimilar license

As Johnson & Johnson’s top moneymaker Stelara nears its patent cliff, biosimilar makers are eager to launch their own versions of the blockbuster immunology med. Now, through a patent settlement, Samsung Bioepis becomes the latest company to score a license to market a Stelara biosim.

Pending an FDA approval of Samsung Bioepis' biosimilar, the license will allow the company to launch on Feb. 22, 2025, Samsung Bioepis said in a statement. 

With the settlement, Sandoz is officially in on the deal too.

The company, which recently completed its split from Novartis, recently struck a deal to commercialize Samsung Bioepis' Stelara biosimilar in the U.S., Canada, Switzerland, the U.K. and countries in Europe.

As for J&J, the drugmaker has inked settlements with several of its potential biosimilar competitors to specify the copycats’ market entry dates. So far, only Amgen’s offering has scored FDA approval.

Amgen’s biosimilar, branded as Wezlana, will likely be the first on the scene with a potential launch date of Jan. 1, 2025. Plus, with an FDA interchangeable designation in hand, the Amgen biosimilar currently boasts an added advantage over other options.

Meanwhile, Teva and Alvotech’s proposed biosimilar was rejected by the FDA last month after a reinspection of Alvotech’s Icelandic manufacturing plant revealed shortcomings. Under the partners’ settlement with J&J, their Stelara version can launch no later than Feb. 21, 2025, which in theory gives the two some time to sort through the issues.

Later entries could include Fresenius Kabi and Formycon’s biosimilar, which has a license date of no later than April 15, 2025, thanks to another J&J patent settlement.

Stelara is a highly attractive target for biosimilar makers. The IL-12/23 inhibitor brought in $9.7 billion for J&J last year.