FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra

EMA Recommends Five New Medicines for Approval

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

FDA Approves Fourth Denosumab Biosimilar

The US Food and Drug Administration (FDA) has approved denosumab-bnht (Conexxence/Bomyntra), manufactured by Fresenius Kabi, for all indications of the reference product denosumab (Prolia/Xgeva). The biosimilar will launch in the United States in June 2025 as part of a global settlement with Amgen, which manufactures the reference product.  The higher dosage of denosumab-bnht (Bomyntra; 120 […] The post FDA Approves Fourth Denosumab Biosimilar f…

FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.

FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.

FDA Approves Denosumab-Bnht as Biosimilar to Prolia, Xgeva

Denosumab-bnht (Conexxence, Bomyntra) became the third biosimilar in 2025 to be approved for denosumab (Prolia, Xgeva).