Last reviewed 2026-04-23 · How we verify

MB09 (denosumab biosimilar)

MB09 is a biosimilar of denosumab that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to suppress osteoclast formation and bone resorption.

MB09 is a biosimilar of denosumab that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to suppress osteoclast formation and bone resorption. Used for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of osteoporosis in postmenopausal women and men at high risk of fracture, Giant cell tumor of bone.

At a glance

Mechanism of action

Denosumab is a fully human monoclonal antibody that binds to RANKL, a key mediator of osteoclast differentiation and activation. By blocking RANKL signaling, it reduces bone turnover and increases bone mineral density. This mechanism is used therapeutically to prevent skeletal-related events in patients with bone metastases and to treat osteoporosis and other bone loss conditions.

Approved indications

• Prevention of skeletal-related events in patients with bone metastases from solid tumors
• Treatment of osteoporosis in postmenopausal women and men at high risk of fracture
• Giant cell tumor of bone

Common side effects

• Hypocalcemia
• Osteonecrosis of the jaw
• Atypical femoral fractures
• Infections
• Back pain

Key clinical trials

• A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis. (PHASE3)
• A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva (PHASE1)

Primary sources

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