The First Denosumab Biosimilar Reaches the US Market

On June 2, 2025, Sandoz announced the launch of its Wyost/Jubbonti denosumab biosimilar, the first of this drug category to be marketed.

In a press release, Keren Haruvi, President, Sandoz North America, stated, “Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients.”

Both versions of the biosimilar are launching with an established Q code (Q5136). Sandoz said that it would be providing “comprehensive support resources for patients who are prescribed [the biosimilars], including reimbursement and financial support.”

Sandoz did not respond to requests about pricing information for Wyost or Jubbonti prior to publication.

The two biosimilar versions of denosumab were approved in March 2024, and had to wait until May 31 to launch, based on an agreement with Amgen, the maker of the reference product. Celltrion’s product is next in line to launch, possibly this week.

In Other Biosimilar News

Samsung Biologics announced plans to spin off its biosimilar division, Samsung Bioepis, into a new company. The move enables Samsung Biologics to separate its contract manufacturing business from its biosimilar manufacturing activities, and to avoid potential conflicts of interest that could inhibit growth, according to the report. Samsung Episholdings will be the new holding company for Samsung Bioepis. The Samsung Bioepis spin off will be made official on October 1.

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