Sandoz, nearing Novartis split, signs up to commercialize Samsung Bioepis' Stelara biosimilar

After plotting a course to grow by leveraging its biosimilar expertise, Sandoz has inked a deal to get involved in one of the industry's next major biosim debuts.

Monday, Sandoz said it signed a deal to commercialize Samsung Bioepis' biosimilar version of Johnson & Johnson's blockbuster immunology med Stelara. The deal covers commercial rights to the product in the U.S., Canada, Switzerland, the U.K. and countries in Europe.

Other terms of the contract are confidential, Sandoz said in a statement.

With the Stelara biosim rights locked up, Sandoz looks forward to five “potential high-value upcoming launches over the next few years," CEO Richard Saynor said in a statement. Those include biosimilars to Biogen’s Tysabri and Regeneron and Bayer’s Eylea.

Stelara is Johnson & Johnson’s top revenue producer and treats several inflammatory diseases including Crohn’s disease, plaque psoriasis, psoriatic arthritis and ulcerative colitis. The IL-12/23 inhibitor brought in $9.7 billion for J&J last year.

With its patents expiring later this year, the drug is a major target for generic and biosimilar companies. As the patent cliff nears, J&J has been busy striking settlements specifying possible market entry dates for some of the biosim players.

As it stands, Amgen holds the earliest Stelara biosimilar launch date under a J&J settlement. Back in May, the companies inked a patent settlement that grants Amgen rights to launch its copycat on January 1, 2025.

And this summer, J&J signed an agreement with Alvotech and Teva that allows the partners to launch their biosimilar by Feb. 21, 2025. Lastly, Fresenius Kabi and Formycon last month signed a deal with J&J to launch their biosimilar "no later than" April 15, 2025.

Importantly, none of the Stelara biosimilars have won FDA approvals. 

Meanwhile, Sandoz will officially split from Novartis on Oct. 4. Despite its recent history of revenue declines, the company is aiming for $3 billion in sales growth over the next five years thanks in part to its deep biosimilar pipeline.