ACVYBRA^® proved bioequivalence to reference product in PK and PD, maintaining comparable efficacy in postmenopausal women with osteoporosis²

STUDY PARTICIPATION = 19 MONTHS

• Randomized, double-blind, multicenter study
• Repeated-dose, parallel-group study
• N = 532 postmenopausal women with
  osteoporosis aged ≥50 years

PK: pharmacokinetics; PD: pharmacodynamics; PMW: postmenopausal women; D: day; M: Month; EoS: end of study; RP: Reference Product; SC: subcutaneous; FU: Follow-Up

ACVYBRA^® showed efficacy equivalent to the reference product in BMD improvement and fracture outcomes²

• Mean % change in hip BMD (from baseline) comparable to the RP group²
• Mean % change in femoral neck BMD (from baseline) comparable to RP group²
• A number of new vertebral fractures comparable to RP group²

• Lumbar spine BMD percent change was comparable among groups^*2

  Month 6

  • ACVYBRA^®
    (SE: 0.863)
  • RP
    (SE: 0.863)

  Month 12

  • ACVYBRA^®
    (SE: 0.870)
  • RP
    (SE: 0.872)

  Month 18

  • ACVYBRA^®
    (SE: 1.260)
  • RP/RP
    (SE: 1.310)
  • RP
    ACVYBRA^®
    (SE: 1.290)

RP: Reference Product; BMD: bone mineral density; SE: standard error *Results in percent change from baseline