Sandoz to Commercialize Samsung Bioepis’ Biosimilar to J&J’s Stelara
Pictured: Novartis headquarters in Basel, Switzerland/iStock, Kannan D
As the Novartis division nears its spin-off, Sandoz will have exclusive rights to commercialize the biosimilar in the U.S., Canada, Switzerland, U.K. and European Economic Area. Financial terms of the Sandoz-Samsung Bioepsis agreement remain confidential, according to Monday’s announcement.
The deal with Samsung Bioepis “will further strengthen our immunology patient offering and means we now have five potential high-value upcoming biosimilar launches over the next few years,” Sandoz CEO Richard Saynor said in a statement.
This list includes its two in-house assets: GP2411, a biosimilar for Amgen’s osteoporosis therapy Prolia (denosumab) and SOK583A1, which mimics Bayer’s blockbuster eye injection Eylea (aflibercept). Sandoz has also partnered with other companies—such as Bio-Thera Solutions, Polpharma Biologics and Biocon—to further deepen its pipeline.
Monday’s commercialization deal will also help Sandoz become a “standalone global leader” in the generics and biosimilars space, according to the announcement.
The contract comes as Sandoz is preparing to spin off into its own separate entity next month. Last week, its parent company Novartis confirmed the spin-off, pending final approval from its shareholders. The Swiss pharma group will hold an extraordinary general meeting on Sept. 15 to secure the go-ahead.
Novartis finalized its plans to spin off Sandoz in August 2022. At the time, a company spokesperson told BioSpace that the move would allow both businesses to maximize value for their shareholders. Nearly a year later, in July 2023, the company’s board unanimously endorsed the spin-off.
Stelara, the reference treatment for SB17, is a monoclonal antibody that works by binding IL-12 and IL-23. It was first approved by the FDA in September 2009 for the treatment of severe plaque psoriasis. It has since picked up nods in other inflammatory diseases, including Crohn’s disease and ulcerative colitis.
Patent protections over one of the molecules used in Stelara’s formulation will expire on Sept. 25.
Several other would-be competitors are already waiting for this impending loss of exclusivity. Amgen is leading the pack and under a May 2023 settlement, its biosimilar can enter the U.S. market no later than Jan. 1, 2025, subject to the FDA’s approval. A month later, J&J also settled with Teva and Alvotech, granting the partners’ biosimilar entry into the U.S. no later than Feb. 1, 2025.