Fresenius receives FDA nod for Prolia, Xgeva biosimilars

The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht).  

These denosumab biosimilars are approved for all indications of the reference products: Prolia (denosumab) and Xgeva (denosumab), respectively. In addition, Fresenius’ operating company has reached a global settlement with Amgen concerning its denosumab biosimilars.

“We are pleased to have reached a global settlement with Amgen for our denosumab biosimilar candidates and to continue to provide patients around the globe with access to high-quality biological medicines. This marks our sixth FDA biosimilar approval, expanding our portfolio to provide more affordable therapies to patients in the U.S.,” said Dr. Sang Jin Pak, president of Fresenius Kabi Biopharma.

[Read more: Fresenius Kabi releases Stelara biosimilar]

Conexxence is approved for use in various adult patient populations at high risk for fractures, including those with osteoporosis, individuals undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. 

Bomyntra is approved for use to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors. It also is used to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy and giant cell tumor of bone in adults and skeletally mature adolescents. 

[Related: Fresenius Kabi, Formycon receive FDA nod for Stelara biosimilar]