Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...more
Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and...more
On February 13, 2025, the FDA approved Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) as the second interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more