{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T16:52:42Z","timestamp":1784307162479,"version":"3.55.0"},"reference-count":2,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T00:00:00Z","timestamp":1745971200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T00:00:00Z","timestamp":1745971200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100014756","name":"Hexal AG","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100014756","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Musculoskeletal"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:sec>\n                    <jats:title>Summary<\/jats:title>\n                    <jats:p>\n                      <jats:bold>What is this summary about?<\/jats:bold>\n                    <\/jats:p>\n                    <jats:p>\n                      This plain language summary describes the results of a clinical study,\n                      <jats:bold>ROSALIA<\/jats:bold>\n                      , which was published in the\n                      <jats:italic toggle=\"yes\">Journal of Bone and Mineral Research<\/jats:italic>\n                      in 2024. The\n                      <jats:bold>ROSALIA<\/jats:bold>\n                      study looked at whether biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      has the same outcomes as the original-brand reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      for treatment in women with postmenopausal\n                      <jats:bold>osteoporosis<\/jats:bold>\n                      .\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:bold>Why was the ROSALIA study done?<\/jats:bold>\n                    <\/jats:p>\n                    <jats:p>\n                      The\n                      <jats:bold>ROSALIA<\/jats:bold>\n                      study compared how well biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      works in comparison to reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      in increasing bone density in women with postmenopausal\n                      <jats:bold>osteoporosis<\/jats:bold>\n                      .\n                      <jats:bold>ROSALIA<\/jats:bold>\n                      also looked at how these medicines affect the body and the immune system, their safety, and the results of switching from treatment with reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      to biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      . The study builds on evidence from previous clinical and non-clinical studies comparing the two medicines.\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:bold>Where can I find the original article on which this summary is based?<\/jats:bold>\n                    <\/jats:p>\n                    <jats:p>\n                      You can read the original article published in the\n                      <jats:italic toggle=\"yes\">Journal of Bone and Mineral Research<\/jats:italic>\n                      at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/dx.doi.org\/10.1093\/jbmr\/zjae016\">http:\/\/dx.doi.org\/10.1093\/jbmr\/zjae016<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>The main results and what they mean<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:bold>ROSALIA<\/jats:bold>\n                      study showed that biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      increased bone density, thus reducing the risk of fractures, to the same degree as reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      . Adverse events, which describe reactions to a medicine outside of the expected treatment effects, were similar in incidence for both treatments and mostly mild to moderate. The presence of \u201canti-drug\u201d antibodies (caused by the immune system trying to neutralize the treatment) was the same in both treatment groups. Both medicines were shown to be processed by the body in the same way. Changing treatment from reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      to biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      did not change how the body reacted to treatment. The results from\n                      <jats:bold>ROSALIA<\/jats:bold>\n                      show that biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      matched reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      and can be used in the same way as reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      for postmenopausal\n                      <jats:bold>osteoporosis<\/jats:bold>\n                      . Furthermore, patients on reference\n                      <jats:bold>denosumab<\/jats:bold>\n                      can be switched to biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      with no issues.\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:bold>Who should read this summary?<\/jats:bold>\n                    <\/jats:p>\n                    <jats:p>\n                      The summary is intended to provide education about biosimilar\n                      <jats:bold>denosumab<\/jats:bold>\n                      to healthcare professionals, patient advocacy groups, and people who have been prescribed Sandoz\n                      <jats:bold>denosumab<\/jats:bold>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1759720x251335147","type":"journal-article","created":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T03:20:56Z","timestamp":1745983256000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Plain language summary of publication to understand the ROSALIA study: a new biosimilar denosumab for bone health"],"prefix":"10.1177","volume":"17","author":[{"given":"Richard","family":"Eastell","sequence":"first","affiliation":[{"name":"Division of Clinical Medicine, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u0142awomir","family":"Jeka","sequence":"additional","affiliation":[{"name":"Clinic and Department of Rheumatology and Systemic Diseases of Connective Tissue, University Hospital No. 2. Bydgoszcz, CM UMK, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Lustberg","sequence":"additional","affiliation":[{"name":"Breast Medical Oncology, Yale Cancer Center, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin","family":"Edgerton","sequence":"additional","affiliation":[{"name":"Articularis Healthcare Group, Summersville, SC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pawe\u0142","family":"\u017buchowski","sequence":"additional","affiliation":[{"name":"Clinic and Department of Rheumatology and Systemic Diseases of Connective Tissue, University Hospital No. 2. Bydgoszcz, CM UMK, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-5563-8631","authenticated-orcid":false,"given":"Barbara","family":"Vogg","sequence":"additional","affiliation":[{"name":"Hexal AG (a Sandoz Company), Holzkirchen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,4,30]]},"reference":[{"key":"e_1_3_4_2_2","volume-title":"Osteoporosis","author":"Porter JL","year":"2023","unstructured":"Porter JL, Varacallo M. Osteoporosis. Treasure Island, FL: StatPearls, 2023."},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.13005\/bpj\/2159"}],"container-title":["Therapeutic Advances in Musculoskeletal Disease"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1759720X251335147","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1759720X251335147","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1759720X251335147","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:40:05Z","timestamp":1777588805000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1759720X251335147"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,30]]},"references-count":2,"alternative-id":["10.1177\/1759720X251335147"],"URL":"https:\/\/doi.org\/10.1177\/1759720x251335147","relation":{},"ISSN":["1759-720X","1759-7218"],"issn-type":[{"value":"1759-720X","type":"print"},{"value":"1759-7218","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,30]]},"article-number":"1759720X251335147"}}