Sandoz Joins Forces with Samsung Bioepis to Bring Game-Changing Biosimilar for J&J’s Stelara to Market

Sandoz Strikes Exclusive Deal with Samsung Bioepis for Game-Changing Biosimilar to J&J’s Stelara

In a groundbreaking move, Sandoz, a division of Novartis, has inked a game-changing agreement with Samsung Bioepis. This strategic partnership centers around SB17, Samsung Bioepis’ biosimilar version of Johnson & Johnson’s highly acclaimed drug, Stelara (ustekinumab).

As Sandoz gears up for its imminent spin-off, this collaboration grants Sandoz exclusive rights to commercialize SB17 in a range of regions, including the U.S., Canada, Switzerland, the U.K., and the European Economic Area. While the financial specifics of this milestone deal are shrouded in secrecy, its potential impact on the pharmaceutical landscape is anything but discreet.

Sandoz’s CEO, Richard Saynor, emphasized the significance of this partnership by stating that it will “further strengthen our immunology patient offering and means we now have five potential high-value upcoming biosimilar launches over the next few years.”

These upcoming launches encompass Sandoz’s two in-house assets, GP2411, a biosimilar for Amgen’s osteoporosis therapy Prolia (denosumab), and SOK583A1, a contender to Bayer’s blockbuster eye injection Eylea (aflibercept). Beyond these, Sandoz has also cultivated strategic alliances with other industry players, including Bio-Thera Solutions, Polpharma Biologics, and Biocon, to bolster its robust pipeline.

Monday’s momentous commercialization agreement marks a significant stride toward Sandoz’s ambition to become a “standalone global leader” in the realm of generics and biosimilars.

This game-changing partnership coincides with Sandoz’s upcoming spin-off, set to become its own independent entity next month. Novartis, Sandoz’s parent company, recently confirmed the impending separation, pending final approval from its shareholders. An extraordinary general meeting is scheduled for September 15, where the decisive vote will take place.

Stelara, the reference treatment for SB17, is a monoclonal antibody renowned for its ability to target IL-12 and IL-23. Initially approved by the FDA in September 2009 for severe plaque psoriasis, it has since earned acclaim for its efficacy in addressing various inflammatory diseases, including Crohn’s disease and ulcerative colitis.

As the patent protection for one of the key molecules in Stelara’s formulation approaches its expiration on September 25, the race among competitors intensifies. Amgen, in particular, is poised to lead the charge, with a settlement allowing its biosimilar entry into the U.S. market no later than January 1, 2025, contingent on FDA approval. In a similar vein, Johnson & Johnson reached settlements with Teva and Alvotech, opening the door for their biosimilars to enter the U.S. market no later than February 1, 2025.

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