Conexxence FDA Approval History

Last updated by Judith Stewart, BPharm on March 29, 2025.

FDA Approved: Yes (First approved March 25, 2025)
Brand name: Conexxence
Generic name: denosumab-bnht
Dosage form: Injection
Company: Fresenius Kabi USA, LLC
Treatment for: Osteoporosis

Conexxence (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

• Conexxence is indicated for:
  - treatment of postmenopausal women with osteoporosis at high risk for fracture.
  - treatment to increase bone mass in men with osteoporosis at high risk for fracture.
  - treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
  - treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.
  - treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
• Conexxence is biosimilar to Prolia and does not have an interchangeability designation.
• Conexxence is administered via subcutaneous injection.
• FDA approval was based on comprehensive analytical development and similarity assessment supported by two comparative clinical studies: a pharmacokinetic, pharmacodynamic, and immunogenicity study in healthy volunteers, and an efficacy, pharmacodynamic, safety, and immunogenicity study in women with postmenopausal osteoporosis.
• Conexxence comes with a Boxed Warning for the increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. Warnings and precautions associated with Conexxence include hypocalcemia, hypersensitivity reactions, osteonecrosis of the jaw, atypical femoral fractures, multiple vertebral fractures following treatment discontinuation, serious infections including skin infections, dermatologic reactions, severe musculoskeletal pain, and suppression of bone turnover.
• Common adverse reactions:
  - Postmenopausal osteoporosis: Common adverse reactions include back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
  - Male osteoporosis: Common adverse reactions include back pain, arthralgia, and nasopharyngitis.
  - Glucocorticoid-induced osteoporosis: Common adverse reactions include back pain, hypertension, bronchitis, and headache.
  - Bone loss due to hormone ablation for cancer: Common adverse reactions include arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
• Conexxence is the fourth FDA-approved biosimilar to Prolia (denosumab) after the approvals of Stoboclo (denosumab-bmwo) and Ospomyv (denosumab-dssb) in 2025, and Jubbonti (denosumab-bbdz) in 2024.
• Bomyntra (denosumab-bnht) was also approved on March 25, 2025 as the fourth biosimilar to Xgeva (denosumab) after the approvals of Osenvelt (denosumab-bmwo) and Xbryk (denosumab-dssb) in 2025, and Wyost (denosumab-bbdz) in 2024.

Development timeline for Conexxence

Further information

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