denosumab

Denosumab is used for those with osteoporosis at high risk for fractures, bone loss due to certain medications, and in those with bone metastases.{{cite web|title=Denosumab|url=https://www.drugs.com/monograph/denosumab.html|publisher=The American Society of Health-System Pharmacists|access-date=16 March 2015|archive-date=30 April 2021|archive-url=https://web.archive.org/web/20210430164801/https://www.drugs.com/monograph/denosumab.html|url-status=live}}

A 2012 meta-analysis found that denosumab was better than placebo, zoledronic acid, and pamidronate, in reducing the risk of fractures in those with cancer.{{cite journal | vauthors = Lipton A, Fizazi K, Stopeck AT, Henry DH, Brown JE, Yardley DA, Richardson GE, Siena S, Maroto P, Clemens M, Bilynskyy B, Charu V, Beuzeboc P, Rader M, Viniegra M, Saad F, Ke C, Braun A, Jun S | title = Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials | journal = European Journal of Cancer | volume = 48 | issue = 16 | pages = 3082–92 | date = November 2012 | pmid = 22975218 | doi = 10.1016/j.ejca.2012.08.002 }}

In those with postmenopausal osteoporosis denosumab decreases the risk of fractures but increases the risk of infection.{{cite journal | vauthors = Zhou Z, Chen C, Zhang J, Ji X, Liu L, Zhang G, Cao X, Wang P | title = Safety of denosumab in postmenopausal women with osteoporosis or low bone mineral density: a meta-analysis | journal = International Journal of Clinical and Experimental Pathology | volume = 7 | issue = 5 | pages = 2113–22 | date = 2014 | pmid = 24966919 | pmc = 4069896 }} A 2013 review concluded that it is a reasonable treatment for postmenopausal osteoporosis.{{cite journal | vauthors = Josse R, Khan A, Ngui D, Shapiro M | title = Denosumab, a new pharmacotherapy option for postmenopausal osteoporosis | journal = Current Medical Research and Opinion | volume = 29 | issue = 3 | pages = 205–16 | date = March 2013 | pmid = 23297819 | doi = 10.1185/03007995.2013.763779 | s2cid = 206967103 }} A 2017 review did not find benefit in males.{{cite journal | vauthors = Nayak S, Greenspan SL | title = Osteoporosis Treatment Efficacy for Men: A Systematic Review and Meta-Analysis | journal = Journal of the American Geriatrics Society | volume = 65 | issue = 3 | pages = 490–495 | date = March 2017 | pmid = 28304090 | pmc = 5358515 | doi = 10.1111/jgs.14668 }}

Bone remodeling is the process by which the body continuously removes old bone tissue and replaces it with new bone.{{cn|date=February 2025}} It is driven by various types of cells, most notably osteoblasts (which secrete new bone) and osteoclasts (which break down bone); osteocytes are also present in bone.{{cn|date=February 2025}}

Precursors to osteoclasts, called pre-osteoclasts, express surface receptors called RANK (receptor activator of nuclear factor-kappa B). RANK is a member of the tumor necrosis factor receptor (TNFR) superfamily. RANK is activated by RANKL (the RANK-Ligand), which exists as cell surface molecules on osteoblasts. Activation of RANK by RANKL promotes the maturation of pre-osteoclasts into osteoclasts. Denosumab inhibits this maturation of osteoclasts by binding to and inhibiting RANKL. Denosumab mimics the natural action of osteoprotegerin, an endogenous RANKL inhibitor, that presents with decreasing concentrations (and perhaps decreased effectiveness) in people with osteoporosis. This protects bone from degradation, and helps to counter the progression of the disease.

It is contraindicated in people with hypocalcemia; sufficient calcium and vitamin D levels must be reached before starting on denosumab therapy.{{cite book|title=Austria-Codex|at=Prolia-Injektionslösung in einer Fertigspritze|editor=Haberfeld, H|publisher=Österreichischer Apothekerverlag|location=Vienna|year=2017|isbn=978-3-85200-196-8|language=de}} Data regarding interactions with other drugs are missing. It is unlikely that denosumab exhibits any clinically relevant interactions.

Denosumab works by lowering the hormonal message that leads to excessive osteoclast-driven bone removal and is active in the body for only six months. Similarly to bisphosphonates, denosumab appears to be implicated in increasing the risk of osteonecrosis of the jaw (ONJ) following extraction of teeth or oral surgical procedures but, unlike bisphosphonate, the risk declines to zero approximately 6 months after injection.{{cite web|url=http://www.todaysgeriatricmedicine.com/archive/110310p6.shtml|title=Injectable Prolia — Osteoporosis Update|access-date=23 March 2016|archive-date=9 March 2021|archive-url=https://web.archive.org/web/20210309195950/https://www.todaysgeriatricmedicine.com/archive/110310p6.shtml|url-status=live}} Invasive dental procedures should be avoided during this time.

The most common side effects are joint and muscle pain in the arms or legs. There is an increased risk of infections such as cellulitis, hypocalcemia (low blood calcium), hypersensitivity allergy reactions, osteonecrosis of the jaw, and atypical femur fractures. Another trial showed significantly increased rates of eczema and hospitalization due to infections of the skin.{{cite journal | vauthors = Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C | title = Denosumab for prevention of fractures in postmenopausal women with osteoporosis | journal = The New England Journal of Medicine | volume = 361 | issue = 8 | pages = 756–65 | date = August 2009 | pmid = 19671655 | doi = 10.1056/NEJMoa0809493 | citeseerx = 10.1.1.472.3489 }} It has been proposed that the increase in infections under denosumab treatment might be connected to the role of RANKL in the immune system.{{cite journal | vauthors = Khosla S | title = Increasing options for the treatment of osteoporosis | journal = The New England Journal of Medicine | volume = 361 | issue = 8 | pages = 818–20 | date = August 2009 | pmid = 19671654 | pmc = 3901579 | doi = 10.1056/NEJMe0905480 }} RANKL is expressed by T helper cells, and is thought to be involved in dendritic cell maturation.{{EntrezGene|8600}} TNFSF11 tumor necrosis factor (ligand) superfamily, member 11; Homo sapiens {{blockquote|also known as RANKL. This protein was shown to be a dentritic cell survival factor and is involved in the regulation of T cell-dependent immune response.}}

Discontinuation of denosumab is associated with a rebound increase in bone turnover. In rare cases this has led to severe hypercalcemia, but is common in children. Vertebral compression fractures have also occurred in some people after discontinuing treatment.{{cite journal | vauthors = Boyce AM | title = Denosumab: an Emerging Therapy in Pediatric Bone Disorders | journal = Current Osteoporosis Reports | volume = 15 | issue = 4 | pages = 283–292 | date = August 2017 | pmid = 28643220 | pmc = 5554707 | doi = 10.1007/s11914-017-0380-1 }}

In August 2009, a meeting was held between Amgen and the Advisory Committee for Reproductive Health Drugs (ACRHD) of the U.S. Food and Drug Administration (FDA) to review the potential uses of denosumab.{{cite web |title=Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting |publisher=PRNewswire/FirstCall |date=13 August 2009 |url=http://www.urotoday.com/3401/browse_categories/prostate_cancer/amgen_issues_statement_on_outcomes_of_advisory_committee_for_reproductive_health_drugs_acrhd_meeting08192009.html |access-date=17 September 2009 |archive-url=https://web.archive.org/web/20131103205109/http://www.urotoday.com/3401/browse_categories/prostate_cancer/amgen_issues_statement_on_outcomes_of_advisory_committee_for_reproductive_health_drugs_acrhd_meeting08192009.html |archive-date=3 November 2013 |url-status=dead }}

In October 2009, the FDA delayed approval of denosumab, stating that it needed more information.{{cite news|url=https://www.nytimes.com/2009/10/20/business/20amgen.html|work=The New York Times|title=F.D.A. Says No to an Amgen Bone Drug|date=19 October 2009|last=Pollack|first=Andrew|access-date=24 February 2017|archive-date=27 January 2018|archive-url=https://web.archive.org/web/20180127135657/http://www.nytimes.com/2009/10/20/business/20amgen.html|url-status=live}}

In June 2010, denosumab was approved by the FDA for use in postmenopausal women with risk of osteoporosis under the brand name Prolia,{{cite web |url=http://www.biosciencetechnology.com/News/FeedsAP/2010/06/fda-clears-amgens-bone-strengthening-drug-prolia/ |title=FDA clears Amgen's bone-strengthening drug Prolia |author=Matthew Perrone |publisher=BioScience Technology |date=2 June 2010 |access-date=2 June 2010 |archive-url=https://web.archive.org/web/20100827180700/http://www.biosciencetechnology.com/News/FeedsAP/2010/06/fda-clears-amgens-bone-strengthening-drug-prolia/ |archive-date=27 August 2010 |url-status=dead }} and in November 2010, as Xgeva for the prevention of skeleton-related events in people with bone metastases from solid tumors.{{cite news |url=http://www.genengnews.com/gen-news-highlights/amgen-s-denosumab-cleared-by-fda-for-second-indication/81244270/ |title=Amgen's Denosumab Cleared by FDA for Second Indication |date=19 November 2010 |access-date=27 November 2010 |archive-date=7 April 2018 |archive-url=https://web.archive.org/web/20180407054018/https://www.genengnews.com/gen-news-highlights/amgen-s-denosumab-cleared-by-fda-for-second-indication/81244270/ |url-status=dead }} Denosumab is the first RANKL inhibitor to be approved by the FDA.{{cite news |url=http://www.medpagetoday.com/Endocrinology/Osteoporosis/20432 |title=FDA Approves Denosumab for Osteoporosis |date=2 June 2010 |access-date=27 November 2010 |archive-date=13 June 2018 |archive-url=https://web.archive.org/web/20180613015439/https://www.medpagetoday.com/endocrinology/osteoporosis/20432 |url-status=live }}

In June 2013, the FDA approved denosumab for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where resection would result in significant morbidity.{{cite web|url=http://www.cancer.gov/cancertopics/druginfo/fda-denosumab|title=FDA Approval for Denosumab|access-date=31 August 2013|archive-date=6 April 2015|archive-url=https://web.archive.org/web/20150406011426/http://www.cancer.gov/cancertopics/druginfo/fda-denosumab|url-status=dead}}

In January 2024, the FDA added a black box warning to Prolia because of the risk of severe hypocalcemia in those with advanced kidney disease. An FDA review found that Prolia had resulted in "hospitalization, life-threatening events, and death" in that population."[https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-drug-safety-communication-fda-adds-boxed-warning-increased-risk-severe-hypocalcemia Prolia (denosumab): Drug Safety Communication - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease] {{Webarchive|url=https://web.archive.org/web/20240406170114/https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-drug-safety-communication-fda-adds-boxed-warning-increased-risk-severe-hypocalcemia |date=6 April 2024 }}". U.S. Food and Drug Administration, 19 January 2024.

In March 2024, the FDA approved applications from Sandoz for Jubbonti (denosumab-bbdz), a biosimilar to Prolia; and Wyost (denosumab-bbdz), a biosimilar to Xgeva.{{Cite web |title=Jubbonti BLA #761362 |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf |access-date=5 March 2024 |website=U.S. Food and Drug Administration (FDA) |archive-date=6 March 2024 |archive-url=https://web.archive.org/web/20240306132521/https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf |url-status=dead }}{{cite press release | title=Sandoz receives FDA approval for first and only denosumab biosimilars | publisher=Sandoz | via=GlobeNewswire | date=5 March 2024 | url=https://www.globenewswire.com/news-release/2024/03/05/2840809/0/en/Sandoz-receives-FDA-approval-for-first-and-only-denosumab-biosimilars.html | access-date=6 March 2024 | archive-date=6 March 2024 | archive-url=https://web.archive.org/web/20240306002156/https://www.globenewswire.com/news-release/2024/03/05/2840809/0/en/Sandoz-receives-FDA-approval-for-first-and-only-denosumab-biosimilars.html | url-status=live }}

In February 2025, the FDA approved denosumab-dssb, sold under the brand name Ospomyv, as a biosimiar to Prolia; and also sold under the brand name Xbryk as a biosimilar to Xgeva.[https://web.archive.org/web/20250215091222/https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761392Orig1s000lbl.pdf fda.gov]{{cite press release | title=FDA Approves Samsung Bioepis Ospomyv, Xbryk (denosumab-dssb), a Biosimilar to Prolia and Xgeva | website=Samsung Bioepis | date=16 February 2025 | url=https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=435¤tPage=1 | access-date=16 February 2025}}

In February 2025, the FDA approved denosumab-bmwo, sold under the brand name Stoboclo, as a biosimiar to Prolia;[https://web.archive.org/web/20250418175541/https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000lbl.pdf fda.gov] and sold under the brand name Osenvelt as a biosimilar to Xgeva.{{cite press release | title=Celltrion receives U.S. FDA approval for Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) biosimilars referencing Prolia and Xgeva | website=Celltrion | date=3 March 2025 | url=https://celltrion.com/en-us/company/media-center/press-release/3768 | access-date=7 March 2025}}

In March 2025, the FDA approved denosumab-bnht, sold under the brand name Bomyntra, as a biosimiar to Prolia;[https://web.archive.org/web/20250328191627/https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf fda.gov] and sold under the brand name Conexxence as a biosimilar to Xgeva.

In December 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion for denosumab for the treatment of postmenopausal osteoporosis in women and for the treatment of bone loss in men with hormone ablation therapy for prostate cancer.{{cite web | publisher = European Medicines Agency (EMA) | title = European Public Assessment Report (EPAR) for Prolia. | date = 16 October 2014 | url = http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/001120/WC500093527.pdf | access-date = 13 April 2015 | archive-date = 4 March 2016 | archive-url = https://web.archive.org/web/20160304191819/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/001120/WC500093527.pdf | url-status = dead }} Denosumab, as Prolia, was authorized for medical use in the European Union in May 2010,{{cite web | title=Prolia EPAR | website=European Medicines Agency | date=26 May 2010 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/prolia | access-date=6 March 2024 | archive-date=16 September 2021 | archive-url=https://web.archive.org/web/20210916120807/https://www.ema.europa.eu/en/medicines/human/EPAR/prolia | url-status=live }}{{cite web | title=Prolia PI | website=Union Register of medicinal products | date=28 May 2010 | url=https://ec.europa.eu/health/documents/community-register/html/h618.htm | access-date=6 March 2024 | archive-date=21 January 2022 | archive-url=https://web.archive.org/web/20220121045940/https://ec.europa.eu/health/documents/community-register/html/h618.htm | url-status=live }} and as Xgeva in July 2011.{{cite web | title=Xgeva EPAR | website=European Medicines Agency | date=13 July 2011 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/xgeva | access-date=6 March 2024 | archive-date=21 September 2023 | archive-url=https://web.archive.org/web/20230921135101/https://www.ema.europa.eu/en/medicines/human/EPAR/xgeva | url-status=live }}{{cite web | title=Xgeva PI | website=Union Register of medicinal products | date=15 July 2011 | url=https://ec.europa.eu/health/documents/community-register/html/h703.htm | access-date=6 March 2024 | archive-date=19 August 2018 | archive-url=https://web.archive.org/web/20180819160038/http://ec.europa.eu/health/documents/community-register/html/h703.htm | url-status=live }}

In March 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Jubbonti, intended for the treatment of osteoporosis in women who have been through menopause and in men at increased risk of fractures whose bone loss is linked to hormone ablation or long-term treatment with systemic glucocorticoid.{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024 | website=European Medicines Agency | date=22 March 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-march-2024 | access-date=13 June 2024}} The applicant for this medicinal product is Sandoz GmbH.{{cite web | title=Jubbonti EPAR | website=European Medicines Agency | date=21 March 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/jubbonti | access-date=23 March 2024 | archive-date=23 March 2024 | archive-url=https://web.archive.org/web/20240323162213/https://www.ema.europa.eu/en/medicines/human/EPAR/jubbonti | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. In March 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Wyost, intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone. The applicant for this medicinal product is Sandoz GmbH.{{cite web | title=Wyost EPAR | website=European Medicines Agency | date=21 March 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/wyost | access-date=23 March 2024 | archive-date=23 March 2024 | archive-url=https://web.archive.org/web/20240323162040/https://www.ema.europa.eu/en/medicines/human/EPAR/wyost | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Denosumab, as Wyost,a biosimilar, was authorized for medical use in the European Union in May 2024 for all indications of denosumab treated by Xgeva.{{Cite web |date=22 May 2024 |title=Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe |url=https://finance.yahoo.com/news/sandoz-receives-european-commission-approval-050000909.html |access-date=23 May 2024 |website=Yahoo Finance}} Denosumab, as Jubbonti, a biosimilar, was authorized for medical use in the European Union in May 2024 for all indications of denosumab treated by Prolia.

In November 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Obodence, intended for the treatment of osteoporosis in women who have been through menopause, treatment of bone loss linked to hormone ablation in men at increased risk of fractures, or treatment of bone loss associated with long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Samsung Bioepis NL B.V. Obodence is a biosimilar medicinal product that is highly similar to the reference product Prolia (denosumab), which was authorized in the EU in May 2010.{{cite web | title=Obodence EPAR | website=European Medicines Agency (EMA) | date=14 November 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/obodence | access-date=16 November 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024 | website=European Medicines Agency (EMA) | date=15 November 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-november-2024 | access-date=16 November 2024}} Obodence was authorized for medical use in the European Union in February 2025.{{cite web | title=Obodence PI | website=Union Register of medicinal products | date=13 February 2025 | url=https://ec.europa.eu/health/documents/community-register/html/h1890.htm | access-date=16 February 2025}}{{cite press release | title=Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (Obodence, Xbryk) | website=Samsung Bioepis | date=16 February 2025 | url=https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=436¤tPage=1 | access-date=16 February 2025}}

In November 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Xbryk, intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. The applicant for this medicinal product is Samsung Bioepis NL B.V. Xbryk is a biosimilar medicinal product that is highly similar to the reference product Xgeva (denosumab), which was authorized in the EU in July 2011.{{cite web | title=Xbryk EPAR | website=European Medicines Agency (EMA) | date=14 November 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/xbryk | access-date=16 November 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Xbryk was authorized for medical use in the European Union in February 2025.{{cite web | title=Xbryk PI | website=Union Register of medicinal products | date=13 February 2025 | url=https://ec.europa.eu/health/documents/community-register/html/h1889.htm | access-date=16 February 2025}}

In December 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Osenvelt, intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. The applicant for this medicinal product is Celltrion Healthcare Hungary Kft. Osenvelt is a biosimilar medicinal product. It is highly similar to the reference product Xgeva which was authorized in the EU in July 2011.{{cite web | title=Osenvelt EPAR | website=European Medicines Agency (EMA) | date=12 December 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/osenvelt | access-date=16 December 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Osenvelt was authorized for medical use in the European Union in February 2025.{{cite press release | title=Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars | publisher=Celltrion | via=Business Wire | date=18 February 2025 | url=https://www.businesswire.com/news/home/20250206269326/en/Celltrion-Expands-Biosimilar-Portfolio-in-the-European-Union-Following-European-Commission-Approval-of-Two-Biosimilars/ | access-date=28 February 2025}}

In December 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Stoboclo, intended for the treatment of osteoporosis in women who have been through menopause, bone loss linked to hormone ablation in men at increased risk of fractures and bone loss associated with long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Celltrion Healthcare Hungary Kft. Stoboclo is a biosimilar medicinal product. It is highly similar to the reference product Prolia, which was authorized in the EU in May 2010.{{cite web | title=Stoboclo EPAR | website=European Medicines Agency (EMA) | date=12 December 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/stoboclo | access-date=16 December 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Stoboclo was authorized for medical use in the European Union in February 2025.

In March 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Jubereq, intended for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. The applicant for this medicinal product is Accord Healthcare S.L.U.{{cite web | title=Jubereq EPAR | website=European Medicines Agency (EMA) | date=27 March 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/jubereq | access-date=28 March 2025}} Jubereq is a biosimilar medicinal product that is highly similar to the reference product Xgeva (denosumab), which was authorized in the EU in July 2011.

In March 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Osvyrti, intended for the treatment of osteoporosis in women who have been through menopause, in men with prostate cancer who are at increased risk of fractures and whose bone loss is linked to hormone ablation, and people whose bone loss is linked to long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Accord Healthcare S.L.U.{{cite web | title=Osvyrti EPAR | website=European Medicines Agency (EMA) | date=27 March 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/osvyrti | access-date=28 March 2025}} Osvyrti is a biosimilar medicinal product that is highly similar to the reference product Prolia (denosumab), which was authorized in the EU in May 2010.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Denosumab BBL, intended for the treatment of osteoporosis in women who have been through menopause, treatment of bone loss linked to hormone ablation in men at increased risk of fractures or treatment of bone loss associated with long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited. Denosumab BBL is a biosimilar medicinal product. It is highly similar to the reference product Prolia (denosumab), which was authorized in the EU in May 2010.{{cite web | title=Denosumab BBL EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/denosumab-bbl | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vevzuo, intended for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited. Vevzuo is a biosimilar medicinal product. It is highly similar to the reference product Xgeva (denosumab), which was authorized in the EU in July 2011.{{cite web | title=Vevzuo EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vevzuo | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yaxwer, intended for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. The applicant for this medicinal product is Gedeon Richter Plc. Yaxwer is a biosimilar medicinal product. It is highly similar to the reference product Xgeva (denosumab), which was authorized in the EU in July 2011.{{cite web | title=Yaxwer EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/yaxwer | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Junod, intended for the treatment of osteoporosis in women who have been through menopause, treatment of bone loss linked to hormone ablation in men at increased risk of fractures or treatment of bone loss associated with long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Gedeon Richter Plc. Junod is a biosimilar medicinal product. It is highly similar to the reference product Prolia (denosumab), which was authorized in the EU in May 2010.{{cite web | title=Junod EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/junod | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zadenvi, intended for the treatment of osteoporosis in women who have been through menopause, treatment of bone loss linked to hormone ablation in men at increased risk of fractures or treatment of bone loss associated with long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Zentiva k.s. Zadenvi is a biosimilar medicinal product. It is highly similar to the reference product Prolia (denosumab), which was authorized in the EU in May 2010.{{cite web | title=Zadenvi EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zadenvi | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Enwylma, intended for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone. The applicant for this medicinal product is Zentiva k.s. Enwylma is a biosimilar medicinal product. It is highly similar to the reference product Xgeva (denosumab), which was authorized in the EU in July 2011.{{cite web | title=Enwylma EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/enwylma | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Denbrayce, intended for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. The applicant for this medicinal product is Mabxience Research S.L. Denbrayce is a biosimilar medicinal product. It is highly similar to the reference product Xgeva (denosumab), which was authorized in the EU in July 2011.{{cite web | title=Denbrayce EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/denbrayce | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

In April 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Izamby, intended for the treatment of osteoporosis in women who have been through menopause, treatment of bone loss linked to hormone ablation in men at increased risk of fractures or treatment of bone loss associated with long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Mabxience Research SL. Izamby is a biosimilar medicinal product. It is highly similar to the reference product Prolia (denosumab), which was authorized in the EU in May 2010.{{cite web | title=Izamby EPAR | website=European Medicines Agency (EMA) | date=25 April 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/izamby | access-date=2 May 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Health Canada approved Jubbonti, a biosimilar to Prolia, in February 2024; and approved Wyost, a biosimilar to Xgeva, in March 2024.

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• {{cite journal | vauthors = Lacey DL, Boyle WJ, Simonet WS, Kostenuik PJ, Dougall WC, Sullivan JK, San Martin J, Dansey R | title = Bench to bedside: elucidation of the OPG-RANK-RANKL pathway and the development of denosumab | journal = Nature Reviews. Drug Discovery | volume = 11 | issue = 5 | pages = 401–19 | date = May 2012 | pmid = 22543469 | doi = 10.1038/nrd3705 | s2cid = 7875371 }}

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{{Drugs for treatment of bone diseases}}

{{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems}}

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Category:Amgen

Category:Monoclonal antibodies

Category:Osteoporosis drugs