Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12 - Takeaways - 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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  • 1

    SB16 is a proposed biosimilar to denosumab, evaluated for efficacy and safety in postmenopausal osteoporosis patients in a phase 3 study.

  • 2

    The study included 457 women with osteoporosis, randomized to receive either SB16 or denosumab at specified intervals.

  • 3

    The primary endpoint was the percent change in lumbar spine bone mineral density at month 12, showing equivalent results between SB16 and denosumab.

  • 4

    Secondary endpoints, including pharmacokinetics and safety profiles, were comparable between the two treatment groups.

  • 5

    Results support the biosimilarity of SB16 to denosumab, indicating its potential as an effective treatment for postmenopausal osteoporosis.

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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