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Last update 15 Sep 2026

Denosumab

Last update 15 Sep 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

anti-RANKL antibody, Denosumab (Genetical Recombination), Denosumab (genetical recombination) (JAN)

+ [14]

Target

RANKL

Action

inhibitors

Mechanism

RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesEndocrinology and Metabolic Disease+ [4]

Active Indication

Bone DiseasesGlucocorticoid-induced osteoporosisHumoral Hypercalcemia of Malignancy+ [12]

Inactive Indication

Advanced breast cancerAdvanced cancerAneurysmal Bone Cysts+ [50]

Originator Organization

Amgen, Inc.

Active Organization

Amgen, Inc.Amgen Europe BV

Amgen Ltd.

+ [7]

Inactive Organization

GSK Plc

Luye Pharma Group Ltd.

Celgene Corp.

+ [2]

License Organization

Dr. Reddy's Laboratories Ltd.

Amgen, Inc.

BeOne Medicines Ltd.

+ [4]

Drug Highest PhaseApproved

First Approval Date

European Union (26 May 2010),

Bone Diseases, MetabolicFractures, BoneOsteoporosis, Postmenopausal

RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 94568L

Source: *****

Sequence Code 143522H

Source: *****

405

Clinical Trials associated with Denosumab

NCT07772609

/ Not yet recruitingPhase 4

Short-course Romosozumab Followed by Denosumab Versus Zoledronic Acid: A Multicentre Randomized Active-controlled Trial in Postmenopausal Women at High Fracture Risk

Osteoporosis is associated with a high risk of fractures, disability, loss of independence, and excess mortality. Zoledronic acid is an established first-line treatment in Sweden, but many patients at high fracture risk remain at substantial residual fracture risk. Short-course treatment with romosozumab followed by denosumab produces large increases in bone mineral density, but has not been directly compared with zoledronic acid.
STRONG-HIP is a multicentre, randomized, active-controlled phase 4 trial in 216 postmenopausal women aged 60 years or older with osteoporosis and high fracture risk. Participants are randomized 1:1 to receive romosozumab 210 mg monthly for 3 months followed by denosumab 60 mg every 6 months, or zoledronic acid 5 mg intravenously at baseline and Month 12.
The primary objective is to determine whether the romosozumab-denosumab sequence produces a greater percentage increase in total hip bone mineral density from baseline to Month 24 than zoledronic acid. Secondary outcomes include total hip and lumbar spine BMD at earlier time points, vertebral and clinical fractures, bone turnover markers, safety, health-related quality of life, and health-economic outcomes. A mechanistic substudy will assess bone microarchitecture and estimated strength using HR-pQCT.
Participants are followed for 24 months in the main study and may enter an optional extension with follow-up to Month 48 to assess the durability of treatment effects.

Start Date11 Jan 2027

Sponsor / Collaborator

Sahlgrenska Universitetssjukhuset

[+8]

CTIS2026-526828-41-00

/ Not yet recruitingPhase 2IIT

Denosumab or Zoledronic acid for erosive hand osteoarthritis (EHOA) in patients with osteoporosis a randomized controlled trial (ZODIAC trial)

Start Date30 Sep 2026

Sponsor / Collaborator

Azienda Ospedaliera Universitaria Integrata Verona

NCT07757373

/ Not yet recruitingPhase 4IIT

Romosozumab Versus Denosumab In Glucocorticoid-induced Osteoporosis: An Extended Observation Of a Randomized Controlled Trial At 6 Years

This is an extended observation study of a RCT comparing the efficacy of romorozumab and denosumab in high-risk patients using long-term glucocorticoids. In the romosozumab arm, patients were shifted to denosumab after the first year. The denosumab arm of patients were continued on denosumab. This study aims to look at the bone mineral density changes in both groups of patients after 6 years.

Start Date01 Sep 2026

Sponsor / Collaborator

Tuen Mun Hospital

100 Clinical Results associated with Denosumab

100 Translational Medicine associated with Denosumab

100 Patents (Medical) associated with Denosumab

6,506

Literatures (Medical) associated with Denosumab

31 Dec 2026·ANNALS OF MEDICINE

Treatment effects of denosumab on refracture and mortality in elderly patients following primary osteoporotic hip fracture surgery: real-world data from a retrospective observational study

Article

Author: Shao, Yunchao ; Cao, Lu ; Xia, Qing ; Jiang, Jiayi ; Wang, Yuzhu

OBJECTIVE:

The effect of denosumab on the risk of refracture and mortality in elderly Chinese patients following primary osteoporotic hip fracture surgery remains to be scarcely investigated. The objective of the study was to investigate the risks of refracture and mortality in elderly patients receiving denosumab .

METHODS:

A retrospective observational study was conducted on elderly patients suffering from primary osteoporotic hip fractures between January 2020 and December 2021 in Zhongshan Hospital, Fudan University. The patients were divided into two groups: denosumab group and control group. PSM and IPTW was performed to adjust between-group differences.

RESULTS:

In this study, 379 patients were observed over a period of three years. Following PSM, denosumab treatment had lower risk of refracture than patients without treatment (13.4% vs. 38.3%, subhazard ratio [SHR] = 0.37, 95%CI = 0.22-0.61, p < 0.0001). A lower mortality rate was observed in patients in the denosumab group compared to the control group within three years postoperatively (HR = 0.45, p = 0.001). In patients aged 65-84 years and those aged 85+ years, denosumab was significantly associated with lower risks of refracture and mortality when compared with the control group (p < 0.05). Denosumab treatment had significantly lower risks of refracture and mortality than patients without treatment in the IPTW analysis (SHR = 0.32, p < 0.0001; HR = 0.41, p = 0.001, respectively).

CONCLUSIONS:

Patients who received treatment with denosumab following primary osteoporotic hip fracture surgery had lower risks of refracture and mortality than patients without treatment, thus underscoring the significance of expeditiously commencing antiosteoporosis treatment in elderly patients after surgery.

CLINICAL TRIAL NUMBER:

Not applicable.

01 Dec 2026·Genes and Nutrition

Quercetin and low-dose gamma irradiation modulate oxidative stress, inflammation, autophagy, and apoptosis in DEN-induced hepatocarcinogenesis

Article

Author: Ali, Mohamed ; Elbakary, Nermeen M ; Maarouf, Rokaya E ; Khatab, Nayera S ; Zahran, Faten

Abstract:

Background:

Diethylnitrosamine (DEN) induces hepatic injury and can promote hepatocarcinogenesis. Quercetin (QR) and low-dose gamma irradiation (LDR) have been explored as hepatoprotective and anticancer-modulating agents, but their combined effects in DEN-induced liver cancer have not been previously examined.

Aim:

To, for the first time, evaluate the novel combination of QR with LDR and compare its efficacy to QR or LDR alone in modulating DEN-induced liver cancer.

Methods:

Hepatic injury was induced in ninety male rats by intraperitoneal DEN administration (75 mg/kg weekly for 3 weeks, then 100 mg/kg weekly for 3 weeks). After 6 weeks, hepatic injury establishment was confirmed histopathologically in a subset of rats. Animals were then randomized into five groups for an 8-week treatment period: (C) normal control; (DEN) no further treatment; (DEN + QR) quercetin (50 mg/kg/day, oral); (DEN + IR) fractionated low-dose γ-irradiation (0.25 Gy once weekly for 4 weeks, total 1 Gy); (DEN + QR+IR) combined QR + IR. The total experimental duration was 14 weeks.

Results:

DEN induced severe hepatotoxicity, with significantly elevated serum ALT and AST compared to controls ( p < 0.001). Markers of oxidative stress were markedly increased, while antioxidant enzymes and GSH were significantly reduced ( p < 0.001). DEN also led to substantial activation of inflammatory and growth signaling pathways, including NF-κB, STAT-3, mTOR, and p38 MAPK ( p < 0.001). Autophagy markers ULK-1, LC3-II, and ATG5 were significantly suppressed, and a pro-survival shift was evident with reduced caspase-3 activity and increased BCL-2 expression ( p < 0.001).Treatment with quercetin (DEN + QR) or low-dose γ-irradiation (DEN + IR) alone significantly mitigated these alterations versus DEN, restoring liver enzymes, reducing oxidative stress and inflammation, and promoting apoptotic signaling ( p < 0.001). The combination therapy (DEN + QR+IR) produced the most pronounced effects, with greater normalization of all biochemical and molecular parameters compared to DEN and to either monotherapy ( p < 0.001). These changes were statistically superior to those observed with quercetin or irradiation alone ( p < 0.01). Flow cytometry confirmed enhanced apoptosis and altered cell cycle dynamics in the combination group. Histopathological analysis showed markedly improved hepatic architecture and the lowest pathology scores with combination therapy ( p < 0.001 vs. DEN).

Conclusion:

This study reveals, for the first time, a combined hepatoprotective effect of quercetin with low-dose gamma irradiation in DEN-induced liver pathology, suggesting new mechanistic insights and promising translational potential for combined therapy in DEN-associated liver injury and hepatocarcinogenesis.

Clinical Trial:

This work isn’t a clinical Trial.

01 Nov 2026·Biomaterials advances

Drug-loaded biomorphic scaffolds for tissue regeneration and targeted antitumor therapy in bone metastasis models

Article

Author: Spadazzi, Chiara ; Montesi, Monica ; Guerrieri, Ania Naila ; Veronesi, Elena ; Donati, Davide Maria ; Bergamini, Valentina ; Liverani, Chiara ; Lucarelli, Enrico ; Bellotti, Chiara ; Cocchi, Claudia ; Dapporto, Massimiliano ; Miserocchi, Giacomo ; Bongiovanni, Alberto ; Gambarotti, Marco ; Ibrahim, Toni ; Sbanchi, Giulia ; Cortesi, Marilisa ; De Vita, Alessandro ; Tavoni, Marta ; Dominici, Massimo ; Casadei, Roberto ; Mercatali, Laura ; Ballardini, Alberto ; Giordano, Emanuele ; Vanni, Silvia ; Sprio, Simone ; Tampieri, Anna ; Morozzi, Giacomo

Renal cell (RCC) and breast carcinoma (BC) frequently develop lytic bone metastases (BM) that are usually treated with systemic and locoregional therapies. Surgery plays a crucial role when pathological fractures or lesions involve a load-bearing bone and consists in the removal of tumor area followed by replacement with implant or prosthesis. In the present study, a proof of concept of novel locoregional therapies for BM patients was evaluated, consisting in the functionalization of biomorphic apatitic scaffolds with proved intrinsic regenerative properties with Everolimus and an anti-RANKL antibody, selected as relevant anticancer and anti-resorptive biomolecules, respectively. Upon confirmation of the biocompatibility of unloaded scaffolds with healthy bone cells, the effective antitumoral activity of released EVE on BC cell lines (MCF-7 and MDA-MB-231) and RCC cell line (Caki-2) was demonstrated. The inhibitory effects of drugs on osteoclast differentiation were validated using peripheral blood mononuclear cells (PBMCs). Preclinical validation was performed on monocultures and cocultures of cancer and bone cells sharing the same culture medium. In silico analyses were exploited to predict cancer cell behavior on medicated scaffolds providing complementary insights while reducing the need for extensive wet-lab experimentation. Finally, as a preliminary proof of translational relevance, the medicated scaffolds were tested with RCC patient-derived explants.

366

News (Medical) associated with Denosumab

31 Aug 2026

·www.globenewswire.com

Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar Program for Entyvio® to Subcutaneous Presentations

REYKJAVIK, Iceland, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration. Under a partnership with Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Alvotech is responsible for the development and manufacturing of AVT80, while Teva is responsible for commercialization. “FDA’s acceptance for review of our BLA for AVT80 is another important milestone for our vedolizumab biosimilar program,” said Joseph McClellan, Chief Operating Officer of Alvotech. “Together with our BLA for AVT16, which was accepted for review in May, the program encompasses both intravenous and subcutaneous presentations, including a prefilled syringe and autoinjector.” Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT80 and the reference product. AVT80 has been submitted as a proposed interchangeable biosimilar. In the United States, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT80 would add to the range of biosimilar options available to patients and healthcare providers in the United States. In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints. Based on regulatory advice, the clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80. About AVT80 and AVT16 AVT80 is a proposed interchangeable biosimilar candidate to Entyvio (vedolizumab), a humanized monoclonal antibody. It is being developed as a prefilled syringe and autoinjector for subcutaneous administration. AVT80 complements AVT16, Alvotech’s proposed interchangeable biosimilar to Entyvio for intravenous administration for which the FDA accepted a BLA for review in May 2026. In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and autoinjector). Together these two candidates form part of Alvotech’s broader pipeline of biosimilar candidates in immunology aimed at expanding access to biologic medicines in major therapeutic areas. AVT16 and AVT80 are investigational products and have not received regulatory approval in any markets. Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed. About Entyvio Entyvio (vedolizumab) is an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. Vedolizumab targets and binds specifically to the alpha-4-beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue. Use of trademarks Entyvio is a registered trademark of Millennium Pharmaceuticals, Inc. The use of this trademark is solely for the purpose of identifying the reference product. Alvotech and Teva do not claim any rights to the trademark. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V PrasadBenedikt StefanssonMikaela Vilchezalvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Clinical ResultDrug Approval

31 Aug 2026

·www.biospace.com

Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations

REYKJAVIK, Iceland, August 31, 2026 - Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration. Under a partnership with Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Alvotech is responsible for the development and manufacturing of AVT80, while Teva is responsible for commercialization. “FDA’s acceptance for review of our BLA for AVT80 is another important milestone for our vedolizumab biosimilar program,” said Joseph McClellan, Chief Operating Officer of Alvotech. “Together with our BLA for AVT16, which was accepted for review in May, the program encompasses both intravenous and subcutaneous presentations, including a prefilled syringe and autoinjector.” Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT80 and the reference product. AVT80 has been submitted as a proposed interchangeable biosimilar. In the United States, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT80 would add to the range of biosimilar options available to patients and healthcare providers in the United States. In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints. Based on regulatory advice, the clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80. About AVT80 and AVT16 AVT80 is a proposed interchangeable biosimilar candidate to Entyvio (vedolizumab), a humanized monoclonal antibody. It is being developed as a prefilled syringe and autoinjector for subcutaneous administration. AVT80 complements AVT16, Alvotech’s proposed interchangeable biosimilar to Entyvio for intravenous administration for which the FDA accepted a BLA for review in May 2026 . In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and autoinjector). Together these two candidates form part of Alvotech’s broader pipeline of biosimilar candidates in immunology aimed at expanding access to biologic medicines in major therapeutic areas. AVT16 and AVT80 are investigational products and have not received regulatory approval in any markets. Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed. About Entyvio Entyvio (vedolizumab) is an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. Vedolizumab targets and binds specifically to the alpha-4-beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue. Use of trademarks Entyvio is a registered trademark of Millennium Pharmaceuticals, Inc. The use of this trademark is solely for the purpose of identifying the reference product. Alvotech and Teva do not claim any rights to the trademark. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Clinical ResultDrug ApprovalBiosimilar

27 Aug 2026

·www.globenewswire.com

Alvotech to present at upcoming investor conferences in September

REYKJAVIK, ICELAND (August 27, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Founder and Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in September as follows: Morgan Stanley 24th Annual Global Healthcare Conference in New York – Fireside chat on Tuesday, September 15, 2026 at 12:20 pm ET (16:20 GMT)Deutsche Bank's 2026 Healthcare Summit in New York – Hosting investor meetings on Thursday, September 17, 2026. A live webcast of the fireside chat will be available to the general public and can be accessed in the Investors Section of Alvotech's website under Events and Presentations. After the event, a recording will be available for replay for 90 days. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V PrasadBenedikt StefanssonMikaela Vilchezalvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Biosimilar

100 Deals associated with Denosumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03684	Denosumab	M05BX04	DB06643

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bone Diseases	United Kingdom	Amgen Ltd.	01 Jan 2021
Glucocorticoid-induced osteoporosis	United States	Amgen, Inc.	18 May 2018
Humoral Hypercalcemia of Malignancy	United States	Amgen, Inc.	04 Jan 2018
Rheumatoid Arthritis	Japan	Daiichi Sankyo Co., Ltd.	03 Jul 2017
Multiple Myeloma	Japan	Amgen, Inc.	18 Jan 2012
Bone Cancer	European Union	Amgen Europe BV	13 Jul 2011
Bone Cancer	Iceland	Amgen Europe BV	13 Jul 2011
Bone Cancer	Liechtenstein	Amgen Europe BV	13 Jul 2011
Bone Cancer	Norway	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	European Union	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	Iceland	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	Liechtenstein	Amgen Europe BV	13 Jul 2011
Giant Cell Tumor of Bone	Norway	Amgen Europe BV	13 Jul 2011
Bone metastases	United States	Amgen, Inc.	18 Nov 2010
Osteoporosis	Australia	Amgen Australia Pty Ltd.	07 Jun 2010
Bone Diseases, Metabolic	European Union	Amgen Europe BV	26 May 2010
Bone Diseases, Metabolic	Iceland	Amgen Europe BV	26 May 2010
Bone Diseases, Metabolic	Liechtenstein	Amgen Europe BV	26 May 2010
Bone Diseases, Metabolic	Norway	Amgen Europe BV	26 May 2010
Bone Diseases, Metabolic	United Kingdom	Amgen Ltd.	26 May 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Atypical anorexia nervosa	Phase 3	United States	Amgen, Inc.	25 Oct 2017
Feeding and Eating Disorders	Phase 3	United States	Amgen, Inc.	25 Oct 2017
Osteogenesis Imperfecta	Phase 3	United States	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Australia	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Belgium	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Bulgaria	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Canada	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Czechia	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	France	Amgen, Inc.	24 Jun 2015
Osteogenesis Imperfecta	Phase 3	Germany	Amgen, Inc.	24 Jun 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2026	Not Applicable	Bone metastases	170	Denosumab Q4W	ulbfavngnr(hbkbrlxxdr) = qxvnuumwdx jvxajgynae (dbeenwurjf, 131.0 - NR)	Non-inferior	12 Sep 2026
				Denosumab Q6W	ulbfavngnr(hbkbrlxxdr) = jeepypggla jvxajgynae (dbeenwurjf, 255.0 - NR)
NCT03030196 (Pubmed \| Endocrine)	Phase 2	Infertility	92	Denosumab	apqarohwsa(kpyinklzpr) = wzqrdorbsd vuvwxwmiyd (tgqvnsihvh )	Negative	25 Jun 2026
				Placebo	cegripbuch(qthghybqun) = kxpwradoik lodgmobfrh (gxgdmhxmva )
EULAR2026	Not Applicable	Osteoarthritis	2,050	Denosumab (Total Hip Arthroplasty)	fxpgnwhkns(ekvplissjx) = high in both groups, with no significant difference between treatments (Figure 1; log-rank p=0.608). sfzjxyumtj (ctxghcpiur ) View more	Negative	11 Jun 2026
				Alendronate (Total Hip Arthroplasty)
EULAR2026	Not Applicable	Osteoporosis	44	Teriparatide	nmeuaufiia(aureefrito) = rtkfxcaqno pekrswagsp (kbrxsyixyi ) View more	Similar	11 Jun 2026
				Denosumab	nmeuaufiia(aureefrito) = cyvcglgexw pekrswagsp (kbrxsyixyi ) View more
ASCO2026	Not Applicable	Metastatic breast cancer	2,023	Denosumab for 13-24 months	dhmqjvvgho(afltsletxd) = qowyaukxng rzvgswjmlv (tqanqvlior )	Positive	29 May 2026
				Denosumab for ≥25 months	ueneghsqqo(aotrvxglxj) = unoixrfria emoaywywlf (vsspxjvdwr, 13.79 - 26.75) View more
NCT02051218 (SAKK 96/12 REDUSE, ASCO2026)	Phase 3	Castration-Resistant Prostatic Cancer	1,380	Denosumab 120 mg Q4W	tkmbkdcdih(hslwmsxlfb) = rhcobagqme sfppisjarl (qyssndffba ) View more	Non-inferior	29 May 2026
				Denosumab 4 loading doses Q4W, followed by Q12W	tkmbkdcdih(hslwmsxlfb) = ssaivgytwf sfppisjarl (qyssndffba ) View more
NCT04711109 (BRCA-P, ASCO2026)	Phase 3	Hereditary Breast and Ovarian Cancer Syndrome BRCA1 mutation	364	Denosumab 120 mg	aopodhxect(rmfabrlqau) = dxvqyrnjxk nbuylavprj (nrgvricgpo ) View more	Positive	29 May 2026
				Placebo	aopodhxect(rmfabrlqau) = pfssccawpf nbuylavprj (nrgvricgpo )
AUA2026	Not Applicable	Bone metastases	624	Denosumab	aoxxbdudyj(noeooswtfg) = rqglwhtrrf niqobwgjee (msyzvewslh ) View more	Positive	15 May 2026
EHA2026	Not Applicable	Malignant Histiocytic Disorders	9	Denosumab	tbnxffnbny(fuhcrcmsmz) = wfoqfvnuiu behoqukxez (xmvqvyrvxt ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Multiple Myeloma	70	Denosumab 120 mg	laufgbgaqd(pfquyfboao) = lgwvctipvn yxkalyrtyt (htjzvlwkqh ) View more	Positive	12 May 2026
				Denosumab 120 mg (NDMM)	wqdkzmtwnu(lobseujhar) = ssqngwahix vyinwqndpx (ovffirzzig ) View more

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