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

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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

 ­ Ref: Samsung Bioepis | Image: Samsung Bioepis

Click here to­ read the full press release 

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