{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T07:49:18Z","timestamp":1753861758171,"version":"3.41.2"},"reference-count":26,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T00:00:00Z","timestamp":1749772800000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aging Medicine"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A prospective, active\u2010controlled, randomized, double\u2010blind, phase III study included postmenopausal women (50\u201380\u2009years of age) with at least 5\u2009years since menopause diagnosed with osteoporosis (<jats:italic>T\u2010SCORE<\/jats:italic>\u2009\u2264\u2009\u22122.5 SD at lumbar spine or femoral neck) randomized 2:1 to receive either Alkem's biosimilar teriparatide or reference teriparatide 20\u2009\u03bcg once daily subcutaneously for 48\u2009weeks. All subjects received calcium 1000\u2009mg 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\u2009weeks. 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 177 patients (114 in biosimilar group and 63 in reference group) were randomized. The percent change from baseline to 48\u2009weeks in lumbar spine BMD (least square mean [LSM] \u00b1 standard error [SE]) was 8.58%\u2009\u00b1\u20090.85 in the biosimilar group and 8.02%\u2009\u00b1\u20091.23 in the reference group. The estimated between\u2010group difference (95% confidence interval [CI]) was \u22120.56% (\u22122.43% to 3.54%) within the prespecified noninferiority margin (\u2212 2.43%), which indicates noninferiority of biosimilar teriparatide compared to reference teriparatide. The percent change in femoral neck BMD from baseline to 48\u2009weeks (LSM\u2009\u00b1\u2009SE) was 3.94%\u2009\u00b1\u20090.83 in the biosimilar group and 2.50%\u2009\u00b1\u20091.20 in the reference group. The estimated between\u2010group difference (95% CI) was 1.44% (\u22121.44% to 4.32%) within the prespecified noninferiority margin (\u22121.44%) indicating noninferiority of biosimilar teriparatide compared to reference teriparatide. Changes in P1NP (serum procollagen type 1 N terminal pro\u2010peptide) were also similar between the groups. Safety profiles, including immunogenicity, were comparable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study established noninferiority, along with comparable safety and immunogenicity between Alkem's biosimilar teriparatide and reference teriparatide in patients with postmenopausal osteoporosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>CTRI number: CTRI\/2018\/05\/014254<\/jats:p><\/jats:sec>","DOI":"10.1002\/agm2.70029","type":"journal-article","created":{"date-parts":[[2025,6,14]],"date-time":"2025-06-14T02:03:16Z","timestamp":1749866596000},"page":"267-274","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Phase 3 Multicenter, Double\u2010Blind Study Comparing Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Alkem's Biosimilar Teriparatide Versus Reference Teriparatide in Postmenopausal Osteoporosis"],"prefix":"10.1002","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9520-2072","authenticated-orcid":false,"given":"Nitin","family":"Kapoor","sequence":"first","affiliation":[{"name":"Christian Medical College  Vellore India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Paul","sequence":"additional","affiliation":[{"name":"Christian Medical College  Vellore India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajeshwar Nath","family":"Srivastava","sequence":"additional","affiliation":[{"name":"King George Medical University  Lucknow India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saurabh","family":"Singh","sequence":"additional","affiliation":[{"name":"Banaras Hindu University  Varanasi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunil","family":"Maheshwari","sequence":"additional","affiliation":[{"name":"Medilink Hospital and Research Centre  Ahmedabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vishal","family":"Patil","sequence":"additional","affiliation":[{"name":"Lifepoint Multispecialty Hospital  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Awadhesh Kumar","family":"Yadav","sequence":"additional","affiliation":[{"name":"Om Surgical Center &amp; Maternity Home  Varanasi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Girish","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Medipoint Hospitals Pvt. Ltd.  Pune India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sushil H.","family":"Mankar","sequence":"additional","affiliation":[{"name":"NKPSIMS and Lata Mangeshkar Hospital  Nagpur India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joe Joseph","family":"Cherian","sequence":"additional","affiliation":[{"name":"St. Johns Medical College Hospital  Bangalore India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Surabhi","family":"Maheshwari","sequence":"additional","affiliation":[{"name":"Medilink Hospital and Research Centre  Ahmedabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-5339-9963","authenticated-orcid":false,"given":"Sudeepti","family":"Srivastava","sequence":"additional","affiliation":[{"name":"King George Medical University  Lucknow India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dattatray","family":"Pawar","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Alkem Laboratories Ltd  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roshan","family":"Pawar","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Alkem Laboratories Ltd  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amol","family":"Aiwale","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Alkem Laboratories Ltd  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amitrajit","family":"Pal","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Alkem Laboratories Ltd  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yogesh","family":"Rane","sequence":"additional","affiliation":[{"name":"Clinical Research Department Alkem Laboratories Ltd  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vinayaka","family":"Shahavi","sequence":"additional","affiliation":[{"name":"Clinical Research Department Alkem Laboratories Ltd  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akhilesh","family":"Sharma","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Alkem Laboratories Ltd  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,6,13]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010004\u20101627\u20100"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S72456"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010004\u20101702\u20106"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1359\/JBMR.0301240"},{"volume-title":"Dietary Reference Intakes for Calcium and Vitamin D","year":"2011","author":"Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium","key":"e_1_2_13_6_1"},{"volume-title":"Assessment of Osteoporosis at the Primary Health Care Level. Technical Report","year":"2007","author":"Kanis J. A.","key":"e_1_2_13_7_1"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13224\u2010017\u20100994\u20103"},{"volume-title":"Forteo (Teriparatide [rDNA Origin] Injection) [Prescribing Information]","year":"2014","key":"e_1_2_13_9_1"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1210\/er.2004\u20100006"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bone.2011.10.018"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1210\/jcem.85.9.6818"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200105103441904"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010010\u20101498\u20105"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00223\u2010012\u20109590\u20109"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bone.2010.05.022"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.165.15.1762"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1359\/jbmr.2003.18.1.9"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43465-023-01012-3"},{"issue":"1","key":"e_1_2_13_20_1","first-page":"937","article-title":"Systematic Review and Meta\u2010Analysis on Prevalence of Osteoporosis in India.","volume":"13","author":"Sabat S. K.","year":"2023","journal-title":"European Journal of Cardiovascular Medicine"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2021.11.009"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.22037\/ijpr.2019.1100679"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP161435.ESGL"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010019\u201005038\u2010y"},{"issue":"9","key":"e_1_2_13_25_1","first-page":"1336","article-title":"Efficacy and Safety of the Biosimilar Recombinant Human Parathyroid Hormone Cinnopar in Postmenopausal Osteoporotic Women: A Randomized Double\u2010Blind Clinical Trial","volume":"47","author":"Tabatabaei\u2010Malazy O.","year":"2018","journal-title":"Iranian Journal of Public Health"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198\u2010018\u201004819\u20101"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1359\/jbmr.060802"}],"container-title":["AGING MEDICINE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/agm2.70029","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,14]],"date-time":"2025-07-14T12:45:51Z","timestamp":1752497151000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/agm2.70029"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":26,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1002\/agm2.70029"],"URL":"https:\/\/doi.org\/10.1002\/agm2.70029","archive":["Portico"],"relation":{},"ISSN":["2475-0360","2475-0360"],"issn-type":[{"type":"print","value":"2475-0360"},{"type":"electronic","value":"2475-0360"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"2024-09-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}