Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12 - Summary - MDSpire

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

  • By

  • Bente Langdahl

  • Yoon-Sok Chung

  • Rafal Plebanski

  • Edward Czerwinski

  • Eva Dokoupilova

  • Jerzy Supronik

  • Jan Rosa

  • Andrzej Mydlak

  • Anna Rowińska-Osuch

  • Ki-Hyun Baek

  • Audrone Urboniene

  • Robert Mordaka

  • Sohui Ahn

  • Young Hee Rho

  • Jisuk Ban

  • Richard Eastell

  • September 7, 2024

  • 0 min

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Objective:

To evaluate the biosimilarity of SB16 to reference denosumab (DEN) in terms of efficacy, safety, pharmacokinetics (including absorption and distribution), pharmacodynamics (including specific biomarkers), and immunogenicity in women with postmenopausal osteoporosis.

Key Findings:
  • The least-squares mean difference in percent change from baseline in lumbar spine BMD at month 12 was 0.33% (90% CI, −0.25 to 0.91) in the full analysis set.
  • Secondary endpoints, including specific changes in BMD at total hip and femoral neck, were comparable between SB16 and DEN treatment groups.
  • Efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.
Interpretation:

SB16 demonstrates comparable efficacy and safety to DEN, supporting its potential as a biosimilar treatment for postmenopausal osteoporosis.

Limitations:
  • Results are based on data up to month 12; longer-term effects and safety beyond this period are not assessed.
  • The study population was limited to women aged 55 to 80 years with specific BMD criteria, which may limit generalizability.
Conclusion:

SB16 is a promising biosimilar to DEN for the treatment of postmenopausal osteoporosis, showing similar efficacy and safety profiles.

Original Source(s)

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

  • by Bente Langdahl, Yoon-Sok Chung, Rafal Plebanski, Edward Czerwinski, Eva Dokoupilova, Jerzy Supronik, Jan Rosa, Andrzej Mydlak, Anna Rowińska-Osuch, Ki-Hyun Baek, Audrone Urboniene, Robert Mordaka, Sohui Ahn, Young Hee Rho, Jisuk Ban, Richard Eastell

  • September 7, 2024

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