Delving into the Latest Updates on Denosumab with Synapse

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+ [6]

Active Indication

Glucocorticoid-induced osteoporosisHumoral Hypercalcemia of MalignancyRheumatoid Arthritis+ [15]

Inactive Indication

Advanced breast cancerAdvanced cancerAdvanced Lung Non-Small Cell Carcinoma+ [44]

Originator Organization

Amgen, Inc.

Active Organization

Luye Pharma Group Ltd.Amgen Europe BV

Amgen, Inc.

+ [5]

Inactive Organization

GSK Plc

Bristol Myers Squibb Co.

Daiichi Sankyo, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

European Union (26 May 2010),

Bone Diseases, MetabolicFractures, BoneOsteoporosis, Postmenopausal

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

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Structure/Sequence

Sequence Code 94568L

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Sequence Code 143522H

Source: *****

This review focuses on recent findi+ngs regarding the management of adverse skeletal effects following weight loss in people living with obesity (PwO). We summarize the guidelines provided by various societies for the prevention and treatment of osteoporosis resulting from bariatric surgery. Next, we discuss the use of traditional antiosteoporosis medications in this population.

Recent Findings:

Guidelines for preventing and treating osteoporosis resulting from bariatric surgery have been recently provided by various societies setting specific treatment criteria for postmenopausal women and men aged ≥ 50 years, based on the occurrence of fragility fractures and/or T-score thresholds. Several studies have highlighted the positive effects of lifestyle changes in preventing high-turnover bone loss; however, data on fracture outcomes are currently unavailable. It is generally accepted that following bariatric procedures, sufficient intake of calcium, vitamin D, and protein, along with regular exercise incorporating progressive, supervised resistance training, is crucial to counteract negative impacts on bone. Regarding the need for medications to combat osteoporosis, most societies recommend zoledronic acid as the preferred choice. This preference is due to the problems associated with oral bisphosphonates, including poor tolerance and absorption issues. Denosumab is typically considered the second choice when bisphosphonates are not suitable or well tolerated. Two randomized controlled studies have recently demonstrated the effectiveness and safety of zoledronic acid and denosumab in addressing high-turnover bone loss.

Summary:

Although guidelines exist for managing skeletal health before and after bariatric surgery, more research is required to validate these recommendations and the use of anti-osteoporosis medications.

01 Dec 2025·European Journal of Trauma and Emergency Surgery

Effectiveness of a co-management program with internal medicine on hip fracture patients at a regional hospital in northwest Spain. Co-inter-Monf study

Article

Author: Marchán-López, Álvaro ; Cambón Cotelo, Javier ; Rodríguez Álvarez, Ana ; Quevedo Vila, Victor ; López-Castro, José

BACKGROUND:

Hip fractures represent a serious public health problem with a high burden of mortality, morbidity, and resource use. Co-management has proven to enhance the clinical outcomes of hip fracture patients hospitalized in various settings.

AIM:

This study aims to evaluate whether the previously observed benefits of co-management can be achieved when such a program is implemented in a rural-based district hospital.

METHODS:

A prospective, single-center observational study was conducted on hip fracture patients hospitalized for hip fracture. Patients were either co-managed by an internal medicine specialist with part-time dedication or not co-managed. The study was conducted in a rural hospital located in Galicia, Northwestern Spain, which serves a population of 45,000.

RESULTS:

A total of 207 patients were included in the study, of whom 97 received co-management. The majority of the patients who were co-managed were female (69.1%) and had a median age of 88 years (interquartile range 83-92). The study showed a high burden of comorbidity with a median Charlson index of 6 points, along with high prevalence rates of dementia (46%), functional disability (50%), and chronic anticoagulant therapy (25%). Despite no differences in age, sex, or preadmission cognitive or functional status, the study found lower 30-day postdischarge mortality in co-managed patients (9.3%) compared with the 110 controls (20.0%, p = 0.049). The prevalence of osteoporosis treatment, both calcium/vitamin D (87.8% vs. 60.7%, p < 0.001) and bisphosphonates/denosumab/teriparatide (42.4% vs. 15.7%, p < 0.001), was higher in the co-managed patients at 30 days after discharge. No differences were observed between the two groups in terms of in-hospital mortality and length of stay.

CONCLUSIONS:

The implementation of internal medicine co-management for hip fracture patients resulted in enhanced outcomes, particularly in the reduction of mortality within 30 days of discharge as well as in the prevalence of osteoporosis treatment.

01 Apr 2025·BONE

Parathyroid hormone levels following denosumab vs. zoledronic acid therapy for osteoporosis

Article

Author: Barzilai-Yosef, Liat ; Rotman-Pikielny, Pnina ; Meron, Michal Kasher ; Lurie, Tzipi Hornik ; Braginski-Shapira, Sofia ; Ramaty, Erez

The objective of this retrospective, database study was to characterize the rate, magnitude and timeline of increases in parathyroid hormone (PTH) levels post-denosumab (DMAb) vs. zoledronic acid (ZA) injection in patients with osteoporosis and near normal baseline PTH. Included were osteoporotic females, ≥50 years, initiating treatment with 60 mg DMAb or 5 mg ZA. PTH levels within 6-months post-DMAb or 12-months post-ZA injection were extracted from the electronic database of a 4.5 million-member health maintenance organization. The indication for PTH measurements was unknown. Exclusion criteria were creatinine >2 mg/dL, vitamin D < 50 nmol/L or parathyroid hormone level > 1.5 × upper limit of normal (ULN). Among 3317 women, 1992 received DMAb and 1325 ZA. The DMAb group was older (73.3 ± 8.5 vs. 69.8 ± 8.6 years, p < 0.001) and more patients treated with DMAb compared with patients treated with ZA had prior non-vertebral fractures (7.7 % vs. 5.2 %, p < 0.01) and had previously been treated with osteoporosis medication (56.3 % vs. 50.3 %, p < 0.001). Among the patients, 14.9 % had at least one post-treatment PTH > 1.5 ULN. Of 7273 post-treatment PTH tests, 62.6 % were within normal limits, while 24.8 % were mildly elevated at 1.01-1.5 ULN. Two-months after both treatments, >1.5 ULN PTH levels peaked at ∼20 %. Elevated PTH was associated with eGFR < 60 mL/min/1.73 m² and comorbidities. In conclusion, most PTH levels post-DMAb or ZA in osteoporotic patients with baseline PTH < 1.5 ULN, were within normal range. PTH increased to >1.5 ULN in 14.9 % of patients; peaking in the first 2-months post-treatment and declining thereafter. Elevated PTH may be related to anti-resorptive effects and is not medication specific. PTH measurements in the first few months post-DMAb and ZA therapy should be limited.

214

News (Medical) associated with Denosumab

19 Mar 2025

·pipelinereview.com

Alvotech and Dr. Reddy’s Announce FDA Acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®

HYDERABAD, India & REYKJAVIK, Iceland I March 18, 2025 I Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”) and Alvotech (NASDAQ: ALVO), a global biotech 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 a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab). “The FDA’s filing acceptance of Dr. Reddy’s proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan Kalawadia, Chief Executive Officer, Dr. Reddy’s North America. “This milestone marks an important step in our mission to improve patient lives by expanding access to affordable and quality biologic medicines. We look forward to being able to serve the large population of patients requiring treatment for osteoporosis and other diseases of the bone,” said Joseph McClellan, Chief Scientific Officer for Alvotech. Prolia® is a prescription biologic medicine used to treat osteoporosis in women after menopause who are at high risk for bone fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well [1]. Xgeva® is a prescription biologic medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors [2]. In May 2024, Dr. Reddy’s and Alvotech entered into a License and Supply Agreement for AVT03. Under the agreement, Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy’s is responsible for registration and commercialization in applicable markets, including the U.S. After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial. About AVT03 AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations. Prolia® is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture [1]. Xgeva® is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone [2]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. References Use of trademarks Prolia® and Xgeva® are registered trademarks of Amgen Inc. About Dr. Reddy’s Laboratories Ltd: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com . About Alvotech Alvotech is a biotech 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. Two biosimilars to Humira ® (adalimumab) and Stelara ® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, 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. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. 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 investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram and YouTube . SOURCE: Alvotech

License out/inDrug Approval

10 Mar 2025

·pmlive.com

FDA approves Celltrion’s denosumab biosimilars Stoboclo and Osenvelt

The US Food and Drug Administration (FDA) has approved Celltrion’s biosimilars referencing Amgen’s bone disease therapy denosumab. The regulator has approved Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo) for all indications covered by Amgen’s Prolia and Xgeva, respectively. Stoboclo has been authorised to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, and to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture. The drug has also been approved to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Meanwhile, Osenvelt is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours, to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity, as well as to treat hypercalcaemia of malignancy refractory to bisphosphonate therapy. A biosimilar, according to the FDA, is a biological medicine that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. Among the clinical evidence supporting the FDA’s decision on Stoboclo and Osenvelt, which are expected to be available in the US in June 2025, were results from phase 3 trials in postmenopausal women with osteoporosis. In the studies, Celltrion’s biosimilars demonstrated equivalent efficacy and pharmacodynamics, as well as similar pharmacokinetics and comparable safety and immunogenicity profiles to reference denosumab. Thomas Nusbickel, chief commercial officer at Celltrion USA, said: “The approval of Stoboclo and Osenvelt is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events. “Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives.”

Clinical ResultDrug ApprovalPhase 3

04 Mar 2025

·pipelinereview.com

Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

Denosumab biosimilar candidates reference Prolia ® and XGEVA ® Amneal looks to expand portfolio to six biosimilars across eight product presentations by 2027 BRIDGEWATER, NJ, USA I March 03, 2025 I Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience (“mAbxience”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia ® and XGEVA ® . mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius. The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. Under the terms of the agreement, mAbxience is responsible for the development and manufacturing of the biosimilars while Amneal will pursue regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience currently partner on ALYMSYS ® , a bevacizumab biosimilar, which was launched in 2022. “Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics. Building on our first three successful biosimilar launches, we look to expand our portfolio next with denosumab, which is an important therapy across multiple indications, including oncology. We are pleased to expand our partnership with mAbxience as we advance our biosimilars pipeline,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. “We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization strategy and applying innovation and cutting-edge R&D technology to create high quality, affordable medicines for underserved patients,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience. Prolia ® : In patients with postmenopausal osteoporosis, the most frequently reported adverse reactions included back musculoskeletal and extremity pain; hypercholesterolemia; and cystitis. Among male patients with osteoporosis, back pain, arthralgia, and nasopharyngitis were reported. Prolia also carries a Boxed Warning for patients with advanced chronic kidney disease. XGEVA ® : The most frequently reported serious adverse reaction was dyspnea. Other reported adverse reactions observed included fatigue, asthenia, hypophosphatemia, and nausea. Discontinuation was reported in patients with osteonecrosis and hypocalcemia. According to IQVIA ® , U.S. annual sales for Prolia ® and XGEVA ® for the 12 months ended December 2024 were approximately $5.0 billion. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn . About mAbxience mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website ( www.mabxience.com ) or connect with us on LinkedIn . SOURCE: Amneal Pharmaceuticals

License out/inAcquisitionDrug Approval

100 Deals associated with Denosumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D03684	Denosumab	M05BX04	DB06643

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
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
Bone Cancer	Japan	Amgen, Inc.	18 Jan 2012
Multiple Myeloma	Japan	Amgen, Inc.	18 Jan 2012
Bone Diseases	European Union	Amgen Europe BV	13 Jul 2011
Bone Diseases	Iceland	Amgen Europe BV	13 Jul 2011
Bone Diseases	Liechtenstein	Amgen Europe BV	13 Jul 2011
Bone Diseases	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
Fractures, Bone	European Union	Amgen Europe BV	26 May 2010

Developing

10 top R&D records.

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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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_SRC2025	Not Applicable	Giant Cell Tumor of Bone	-	Denosumab	wenccupyhk(sqstrlhhho) = bvikjwuqmx dafhamdbii (dtvfaiqbsl ) View more	Positive	21 Mar 2025
				denosumab (Control Group)	wenccupyhk(sqstrlhhho) = rskdquuojt dafhamdbii (dtvfaiqbsl ) View more
NCT00896454 (Study 20070315, FDA_CDER) Manual	Phase 2	Hypercalcemia	33	Denosumab	ponjhyjuwy(ctfhuwyqet) = erlopkhdfn ohkkpdfikk (tjheietuke, 45.1 - 79.6) View more	Positive	28 Feb 2025
NCT00330759 \| NCT00321464 \| NCT00321620 (Study 20050103, FDA_CDER) Manual	Phase 3	Bone metastases	-	Denosumab (Study 20050136 Metastatic Breast Cancer)	tpogojtpzo(vrhbntdvpv) = ljcmglensw rhtzdfzsgz (uasustlhye ) View more	Positive	28 Feb 2025
				Zoledronic Acid (Study 20050136 Metastatic Breast Cancer)	tpogojtpzo(vrhbntdvpv) = birzwsynpw rhtzdfzsgz (uasustlhye ) View more
NCT01345019 (Study 20090482, FDA_CDER) Manual	Phase 3	Multiple Myeloma	859	Denosumab (Study 20090482 Multiple Myeloma)	smqwnssfhz(pwcrxkqnve) = ifmfcvglxv urlhgvswpz (nqoxyevyiy ) View more	Non-inferior	28 Feb 2025
				Zoledronic Acid	smqwnssfhz(pwcrxkqnve) = vgmdyydvpn urlhgvswpz (nqoxyevyiy ) View more
NCT00396279 \| NCT00680992 (Study 20062004, FDA_CDER) Manual	Phase 2	Giant Cell Tumor of Bone	187	Denosumab 120 mg	rtcnlvcsjf(hsgpjevtwa) = pxowtbonqu jxxlgdxnst (qvykaseznk, 19 - 32) View more	Positive	28 Feb 2025
NCT02771860 (CTgov)	Phase 2	Osteoarthritis	100	Denosumab (Active Comparator: Experimental: Denosumab)	oszcvdpoba(eyjulwpylb) = ihhnjknaxn dfswvewlfm (vooqkjpocn, 2.4) View more	-	25 Sep 2024
				placebo+denosumab (Comparator - Placebo)	oszcvdpoba(eyjulwpylb) = iefcqfyhbi dfswvewlfm (vooqkjpocn, 3.2) View more
NCT02753283 (PROUD, CTgov)	Phase 4	Osteoporotic Fractures \| Osteoporosis, Postmenopausal	201	Vitamin D+denosumab (Women Denosumab)	twujnvrijh(dvppkpxwdu) = swoitktqyt gigvniydnq (dezdksblxw, 0.62) View more	-	19 Sep 2024
				Placebo (Women Placebo Group)	twujnvrijh(dvppkpxwdu) = szwgnjglhv gigvniydnq (dezdksblxw, 0.79) View more
ESMO2024	Not Applicable	Metastatic breast cancer	-	Zoledronic acid (ZA)	vlnshifppi(dhcdbnkyri) = Dmab had a significant analgesic effect respect to ZA: patients on Dmab were 89% less likely to increase one step on the WHO ladder. They also showed a reduction on average of 0.4 points (-0.67, -0.12, 95% CI) on the numerical rating scale. Finally, patients on Dmab took an average 0.77 mg OME dose (0.22-2.94, 95% CI) compared with 6.24 mg OME dose (3.6- 18, 95% CI) of ZA patients phcsorzcgh (fkusrmanqn )	-	15 Sep 2024
				Denosumab (Dmab)
ESMO2024	Not Applicable	Aneurysmal Bone Cysts Adjuvant \| Second line	67	Denosumab	jfmdvxgucn(xyehmniwiy) = Hypercalcemia manifested 2.5-6 months post-discontinuation, often managed with bisphosphonates. Less than 50% of studies had follow-up periods exceeding two years. bwknxtgwaz (flforqeqiy ) View more	Positive	14 Sep 2024
NCT02132026 (SALTIRE2, Pubmed \| J Am Heart Assoc)	Phase 3	Vascular Calcification 18F‐sodium fluoride	-	Denosumab	jqjyepcmba(ttrsougrys) = hqivreqhvu kwzmahimwv (fbaceuzohg, 0 - 212) View more	Negative	09 Sep 2024
				Alendronic acid	jqjyepcmba(ttrsougrys) = ytcteeohip kwzmahimwv (fbaceuzohg, -62 to 134) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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