Publications

Objective: The primary purpose of this study was to compare the efficacy and safety of proposed biosimilar teriparatide with reference
teriparatide in patients of postmenopausal osteoporosis. The secondary objectives were to assess the pharmacodynamic
response of study drugs in postmenopausal osteoporosis and to assess the pharmacokinetic profile of biosimilar and reference
teriparatide in a subset of subjects (a total of 30 evaluable subjects i.e., 15 subjects in reference arm and 15 subjects in biosimilar
arm).
Methods: A prospective, active-controlled,
randomized, double-blind,
phase III study included postmenopausal women (50–
80 years of age) with at least 5 years since menopause diagnosed with osteoporosis (T-SCORE
≤ −2.5 SD at lumbar spine or femoral
neck) randomized 2:1 to receive either Alkem's biosimilar teriparatide or reference teriparatide 20 μg once daily subcutaneously
for 48 weeks. All subjects received calcium 1000 mg and vitamin D3 500 IU once daily orally. The primary efficacy endpoint was
percent change in bone mineral density (BMD) at lumbar spine and femoral neck from baseline to 48 weeks. Safety outcomes,
pharmacokinetics, and immunogenicity were also evaluated. Secondary endpoints included change from baseline in pharmacodynamic
parameters like serum P1NP, which were analyzed at randomization, at week 12, 24, and 48.
Results: In total, 177 patients (114 in biosimilar group and 63 in reference group) were randomized. The percent change from
baseline to 48 weeks in lumbar spine BMD (least square mean [LSM] ± standard error [SE]) was 8.58% ± 0.85 in the biosimilar
group and 8.02% ± 1.23 in the reference group. The estimated between-group
difference (95% confidence interval [CI]) was
−0.56% (−2.43% to 3.54%) within the prespecified noninferiority margin (− 2.43%), which indicates noninferiority of biosimilar
teriparatide compared to reference teriparatide. The percent change in femoral neck BMD from baseline to 48 weeks (LSM ± SE)
was 3.94% ± 0.83 in the biosimilar group and 2.50% ± 1.20 in the reference group. The estimated between-group
difference (95%