A Phase 3 Multicenter, Double‐Blind Study Comparing Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Alkem's Biosimilar Teriparatide Versus Reference Teriparatide in Postmenopausal Osteoporosis

A Phase 3 Multicenter, Double‐Blind Study Comparing Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Alkem's Biosimilar Teriparatide Versus Reference Teriparatide in Postmenopausal Osteoporosis

ABSTRACT 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 postmenopausa...

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Main Authors: Nitin Kapoor, Thomas Paul, Rajeshwar Nath Srivastava, Saurabh Singh, Sunil Maheshwari, Vishal Patil, Awadhesh Kumar Yadav, Girish Bhatia, Sushil H. Mankar, Joe Joseph Cherian, Surabhi Maheshwari, Sudeepti Srivastava, Dattatray Pawar, Roshan Pawar, Amol Aiwale, Amitrajit Pal, Yogesh Rane, Vinayaka Shahavi, Akhilesh Sharma
Format: Article
Language:English
Published: Wiley 2025-06-01
Series:Aging Medicine
Subjects:
biosimilar
bone mineral density
PN1P
postmenopausal osteoporosis
teriparatide
Online Access:https://doi.org/10.1002/agm2.70029
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https://doi.org/10.1002/agm2.70029

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