Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12.
Bente LangdahlYoon-Sok ChungRafal PlebanskiEdward CzerwinskiEva DokoupilovaJerzy SupronikJan RosaAndrzej MydlakAnna Rowińska-OsuchKi-Hyun BaekAudrone UrbonieneRobert MordakaSohui AhnYoung Hee RhoJisuk BanRichard EastellPublished in: The Journal of clinical endocrinology and metabolism (2024)
The reported efficacy, PK, PD, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.