Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

 Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Shots:

  • The P-lll study will assess the efficacy, safety, pharmacokinetics PK/PD, and immunogenicity of SB16 vs Prolia in 432 female volunteers for postmenopausal osteoporosis
  • The company has initiated the P-I study to compare the PK/PD, safety, tolerability, and immunogenicity b/w SB16 and Prolia in healthy volunteers in Oct’2020
  • Samsung Bioepis has three biosimilar candidates – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in P-III development

Click here ­to­ read full press release/ article | Ref: Samsung Bioepis | Image: BusinessWire