{"id":"mb09-denosumab-biosimilar","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypocalcemia"},{"rate":null,"effect":"Osteonecrosis of the jaw"},{"rate":null,"effect":"Atypical femoral fractures"},{"rate":null,"effect":"Infections"},{"rate":null,"effect":"Back pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"MB09 is a biosimilar of denosumab that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand) to suppress osteoclast formation and bone resorption.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:49:52.712Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of skeletal-related events in patients with bone metastases from solid tumors"},{"name":"Treatment of osteoporosis in postmenopausal women and men at high risk of fracture"},{"name":"Giant cell tumor of bone"}]},"trialDetails":[{"nctId":"NCT05338086","phase":"PHASE3","title":"A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.","status":"COMPLETED","sponsor":"mAbxience Research S.L.","startDate":"2022-03-16","conditions":"Postmenopausal Women With Osteoporosis","enrollment":558},{"nctId":"NCT05299073","phase":"PHASE1","title":"A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva","status":"COMPLETED","sponsor":"mAbxience Research S.L.","startDate":"2022-03-01","conditions":"Healthy Volunteers","enrollment":257}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"MB09 (denosumab biosimilar)","genericName":"MB09 (denosumab biosimilar)","companyName":"mAbxience Research S.L.","companyId":"mabxience-research-s-l","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}