地舒单抗生物类似药（ Alvotech）(Denosumab biosimilar (Alvotech)) - 药物靶点：RANKL_在研适应症：性腺功能低下性骨质疏松症，骨癌，代谢性骨病_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Denosumab Biosimilar (Alvotech hf)、デノスマブ（遺伝子組換え）［デノスマブ後続1］（JAN）（富士製薬工業株式会社）、地舒单抗生物类似药（Alvotech hf）

+ [9]

靶点

RANKL

作用方式

抑制剂

作用机制

RANKL抑制剂(肿瘤坏死因子配体超家族成员11抑制剂)

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [4]

在研适应症

性腺功能低下性骨质疏松症骨癌代谢性骨病+ [12]

非在研适应症-

原研机构

Alvotech hf

在研机构

Reddy Holding GmbH

STADA Arzneimittel AGAlvotech

+ [5]

非在研机构

Alvotech Swiss AG

权益机构

Fuji Pharma Co., Ltd.

Alvotech hf

STADA Arzneimittel AG

+ [5]

最高研发阶段批准上市

首次获批日期

日本 (2025-09-19),

多发性骨髓瘤转移性肿瘤实体瘤

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 94568L

当前序列信息引自: *****

Sequence Code 143522H

当前序列信息引自: *****

关联

3

项与地舒单抗生物类似药（ Alvotech）相关的临床试验

NCT05876949

/ Completed临床1期

A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects

This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old. The study will assess the PK, safety and tolerability of AVT03 compared to US-Xgeva when administered as a single 120 mg SC dose

开始日期2023-07-21

申办/合作机构

Alvotech Swiss AG

NCT05395091

/ Completed临床3期

A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.

开始日期2022-08-23

申办/合作机构

Alvotech Swiss AG

NCT05126784

/ Completed临床1期

A Randomized, Double-blind, Single-dose, Parallel-group Design, 2 Arm Study Comparing the Pharmacokinetic, Pharmacodynamic, Safety, Tolerability, and Immunogenicity Profiles of AVT03 and Prolia® in Healthy Male Subjects

This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old. The study will assess the PK, PD, safety, tolerability and immunogenicity of AVT03 compared to Prolia when administered as a single SC dose.

开始日期2022-06-29

申办/合作机构

Alvotech Swiss AG

100 项与地舒单抗生物类似药（ Alvotech）相关的临床结果

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100 项与地舒单抗生物类似药（ Alvotech）相关的转化医学

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100 项与地舒单抗生物类似药（ Alvotech）相关的专利（医药）

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3

项与地舒单抗生物类似药（ Alvotech）相关的文献（医药）

2025-08-03·EXPERT OPINION ON BIOLOGICAL THERAPY

A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis

Article

作者: Serena Stamatakos ; Lukasz Jaskiewicz ; Masna Rai ; Steffen Leutz ; Abid Sattar ; Hendrik Otto ; Tobie de Villiers ; Fausto Berti ; Grzegorz Kania ; Halimu Haliduola ; Mamuka Lortkipanidze ; Felicitas Bullo

BACKGROUND:

To demonstrate comparative efficacy of AVT03, a proposed denosumab biosimilar, versus reference product (RP) in postmenopausal women with osteoporosis.

RESEARCH DESIGN AND METHODS:

Participants received AVT03 or RP; 60 mg subcutaneous on Day 1 and Month 6. At Month 12, AVT03 group received 3^rd dose while RP group received either a 3^rd dose of RP or a dose of AVT03. Primary endpoints were percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months and area under the effect curve (AUEC)_0-6 months of percent change from baseline (%Cfb) in serum C-terminal telopeptide of type I collagen (sCTX-1). Safety and immunogenicity were evaluated.

RESULTS:

The 95% confidence interval (CI)s of the least squares means difference between treatments for percent change from baseline in lumbar spine BMD to Month 12 (-0.58, 0.82) were entirely contained within the prespecified margin (-1.45%, 1.45%), supporting demonstration of comparative efficacy. The 95% CIs of the geometric mean ratio between treatments for AUEC_0-6 months of %Cfb sCTX-1 (0.97, 1.03) were entirely contained within the prespecified margin (0.80, 1.25), supporting demonstration of pharmacodynamic similarity. Safety and immunogenicity profiles were comparable throughout.

CONCLUSION:

Data supported demonstration of comparative efficacy between AVT03 and RP denosumab. Safety and immunogenicity profiles were similar.

TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT05395091.

2025-06-03·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, pharmacodynamic, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (60 mg/mL) in healthy male adults

Article

作者: Lukasz Jaskiewicz ; Masna Rai ; Ruth Ruffieux ; Steffen Leutz ; Fausto Berti ; Hendrik Otto ; Felicitas Bullo ; Serena Stamatakos ; Anel Pretorius ; Abid Sattar

BACKGROUND:

This study compared pharmacokinetic (PK) similarity, pharmacodynamic, safety, and immunogenicity of AVT03, a candidate biosimilar, with reference product (RP) denosumab (Prolia).

METHODS:

Healthy male participants (N = 209) were randomized 1:1 to receive one 60 mg dose of either AVT03 or RP. PK similarity was demonstrated if the 90% confidence intervals (CI) for the ratio of geometric means for the primary PK parameters (C_max and AUC_0-inf for EMA; C_max and AUC_0-t for FDA and PMDA) were within the prespecified margins of 80.00% and 125.00%. Secondary PK parameters assessed were AUC_0-24, T_max, K_el, t_1/2, V_z/F, and CL/F. The serum biomarker of bone resorption, CTX-1 was evaluated to compare pharmacodynamic (PD) profiles. Safety and immunogenicity were also assessed.

RESULTS:

The 90% CI for the ratio of geometric means for primary PK parameters was contained between the pre-specified margins of 80.00% and 125.00% (C_max [102.23, 113.64]; AUC_0-inf [107.17, 118.87]; AUC_0-t [107.72, 120.42]), supporting demonstration of PK similarity between AVT03 and RP. Secondary PK parameters supported the analysis. PD, safety and immunogenicity profiles were comparable between the two arms.

CONCLUSION:

Results supported a demonstration of PK similarity between AVT03 and RP denosumab. Comparable PD, safety and immunogenicity profiles were also shown.

CLINICAL TRIAL REGISTRATION:

The clinical trial is registered at https://www.clinicaltrials.gov under identifier NCT05126784.

2025-06-03·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (70 mg/mL) in healthy male adults

Article

作者: Rai, Masna ; Otto, Hendrik ; Stamatakos, Serena ; Berti, Fausto ; Jaskiewicz, Lukasz ; Leutz, Steffen ; Bullo, Felicitas ; Tomaszewska-Kiecana, Monika ; Sattar, Abid

BACKGROUND:

This study (NCT05876949) compared the pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT03, a candidate biosimilar, with reference product (RP) denosumab (Xgeva).

METHODS:

Healthy male participants (N = 208, including 24 Japanese participants) were randomized 1:1 to receive one 120 mg dose of AVT03, or RP. PK similarity was demonstrated if the 90% confidence intervals (CI) for the ratio of geometric means for the primary PK parameters C_max and AUC_0-t were within 80.00% and 125.00%. Additional PK parameters included AUC_0-inf, t_max, K_el, t_1/2, V_z/F, and CL/F. Safety and immunogenicity were also assessed.

RESULTS:

The 90% CIs for the ratio of geometric means for the primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (C_max [98.26, 110.00]; AUC_0-t [102.30, 113.60]), supporting demonstration of PK similarity. Consistency between Japanese participants and the overall population was shown. Safety and immunogenicity profiles were comparable between the two treatment arms.

CONCLUSION:

Results supported demonstration of PK similarity between AVT03 and RP. AVT03 had a safety and immunogenicity profile comparable to RP.

CLINICAL TRIAL REGISTRATION:

The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05876949); and 2022 -003,659-32 (EudraCT).

74

项与地舒单抗生物类似药（ Alvotech）相关的新闻（医药）

2026-11-02

·GlobeNewswire-Health Care

Alvotech to Present at Upcoming Investor Conferences in November

REYKJAVIK, Iceland, Nov. 02, 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 members of the management team will participate in upcoming investor conferences in November as follows: UBS Global Biopharma Conference in London– fireside chat Tuesday, November 17 at 14:00 GMT (9:00 am ET).2026 Jefferies Global Healthcare Conference in London – presentation on Wednesday, November 18 at 14:30 GMT (9:30 am ET)DNB Carnegie Healthcare Conference in Oslo – fireside chat on Tuesday, November 24 at 13:20 CET (7:20 am ET).SEB Healthcare Seminar in Stockholm– fireside chat on Wednesday, November 25 at 10:40 CET (4:40 am ET). Live audio webcasts will be available to investors and the general public on Alvotech’s website on our Events and Presentations page: https://www.alvotech.com/events in the 2026 Q4 section. After the live webcasts, a recording will also be available for up to 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 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. 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.

生物类似药

2026-11-02

·GlobeNewswire-Health Care

Alvotech to Present at Upcoming Investor Conferences in November

REYKJAVIK, ICELAND (November 2, 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 members of the management team will participate in upcoming investor conferences in November as follows: UBS Global Biopharma Conference in London– fireside chat Tuesday, November 17 at 14:00 GMT (9:00 am ET).2026 Jefferies Global Healthcare Conference in London – presentation on Wednesday, November 18 at 14:30 GMT (9:30 am ET)DNB Carnegie Healthcare Conference in Oslo – fireside chat on Tuesday, November 24 at 13:20 CET (7:20 am ET).SEB Healthcare Seminar in Stockholm– fireside chat on Wednesday, November 25 at 10:40 CET (4:40 am ET). Live audio webcasts will be available to investors and the general public on Alvotech’s website on our Events and Presentations page: https://www.alvotech.com/events in the 2026 Q4 section. After the live webcasts, a recording will also be available for up to 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 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. 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.

生物类似药

2026-11-02

·BioSpace

Alvotech to Present at Upcoming Investor Conferences in November 2026

REYKJAVIK, ICELAND (November 2, 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 members of the management team will participate in upcoming investor conferences in November as follows: UBS Global Biopharma Conference in London– fireside chat Tuesday, November 17 at 14:00 GMT (9:00 am ET). 2026 Jefferies Global Healthcare Conference in London – presentation on Wednesday, November 18 at 14:30 GMT (9:30 am ET) DNB Carnegie Healthcare Conference in Oslo – fireside chat on Tuesday, November 24 at 13:20 CET (7:20 am ET). SEB Healthcare Seminar in Stockholm – fireside chat on Wednesday, November 25 at 10:40 CET (4:40 am ET). Live audio webcasts will be available to investors and the general public on Alvotech’s website on our Events and Presentations page: in the 2026 Q4 section. After the live webcasts, a recording will also be available for up to 90 days. 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 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. 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 .

生物类似药

100 项与地舒单抗生物类似药（ Alvotech）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03684	地舒单抗生物类似药（ Alvotech）	M05BX04	DB06643

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
性腺功能低下性骨质疏松症	英国	Dr. Reddy's Laboratories (UK) Ltd.	2025-12-05
骨癌	欧盟	Alvotech	2025-11-25
骨癌	冰岛	Alvotech	2025-11-25
骨癌	列支敦士登	Alvotech	2025-11-25
骨癌	挪威	Alvotech	2025-11-25
代谢性骨病	欧盟	Alvotech	2025-11-25
代谢性骨病	冰岛	Alvotech	2025-11-25
代谢性骨病	列支敦士登	Alvotech	2025-11-25
代谢性骨病	挪威	Alvotech	2025-11-25
骨质疏松症	欧盟	Alvotech	2025-11-25
骨质疏松症	冰岛	Alvotech	2025-11-25
骨质疏松症	列支敦士登	Alvotech	2025-11-25
骨质疏松症	挪威	Alvotech	2025-11-25
自发性骨折	欧盟	Reddy Holding GmbH	2025-11-17
自发性骨折	欧盟	STADA Arzneimittel AG	2025-11-17
自发性骨折	冰岛	STADA Arzneimittel AG	2025-11-17
自发性骨折	冰岛	Reddy Holding GmbH	2025-11-17
自发性骨折	列支敦士登	STADA Arzneimittel AG	2025-11-17
自发性骨折	列支敦士登	Reddy Holding GmbH	2025-11-17
自发性骨折	挪威	Reddy Holding GmbH	2025-11-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨质疏松性骨折	申请上市	欧盟	Reddy Holding GmbH	2025-09-18
骨质疏松性骨折	申请上市	欧盟	STADA Arzneimittel AG	2025-09-18
免疫系统疾病	临床前	冰岛	Alvotech hf	-
肿瘤	临床前	冰岛	Alvotech hf	-

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05876949 (AVT03-GL-P03, CTgov)	临床1期	-	208	AVT03 (Experimental Arm AVT03 120mg)	遞衊觸壓艱憲膚襯餘餘(餘鏇夢餘範鹽壓衊醖遞) = 糧選淵繭夢獵襯築糧壓憲鏇醖鏇憲齋積鏇獵齋 (鹹鏇淵憲鹽繭衊觸蓋鏇, 34) 更多	-	2025-05-15
				Denosumab (Active Comparator Xgeva 120mg)	遞衊觸壓艱憲膚襯餘餘(餘鏇夢餘範鹽壓衊醖遞) = 淵壓齋餘蓋範餘憲鑰築憲鏇醖鏇憲齋積鏇獵齋 (鹹鏇淵憲鹽繭衊觸蓋鏇, 32) 更多
NCT05395091 (WCO_IOF_ESCEO2025)	临床3期	绝经期后骨质疏松	532	AVT03	窪鏇齋鬱築觸糧餘顧襯(窪蓋鹹觸觸醖衊鬱鹹顧): Geometric mean ratio = 1.0 (95.0% CI, 0.97 ~ 1.03)	积极	2025-04-10
				Reference Product (RP) DENOSUMAB
NCT05876949 (WCO_IOF_ESCEO2025)	临床1期	-	208	AVT03	鬱艱襯鏇簾壓糧壓繭齋(窪願窪鑰簾壓淵襯窪蓋) = 獵醖網願衊願獵範衊鏇網憲齋鏇獵鹹觸衊遞齋 (鏇簾積憲衊膚築積襯積 )	积极	2025-04-10
				Reference Product	鬱艱襯鏇簾壓糧壓繭齋(窪願窪鑰簾壓淵襯窪蓋) = 鹹醖繭窪遞願鹽醖繭糧網憲齋鏇獵鹹觸衊遞齋 (鏇簾積憲衊膚築積襯積 )
NCT05126784 (WCO_IOF_ESCEO2025)	临床1期	-	206	AVT03 (60 mg/mL)	-	积极	2025-04-10
				Reference Product (60 mg/mL)
NCT05876949 (AVT03-GL-P03, GlobeNewswire) 人工标引	临床1期	绝经期后骨质疏松	208	AVT03	鹽繭醖醖顧夢製願鑰鑰(願鏇鬱糧築窪選顧齋窪) = we have now obtained positive topline results from two PK studies, that show equivalent PK, safety, and tolerability of AVT03 compared to Prolia and Xgeva, respectively. 願廠醖簾糧齋齋壓齋壓 (鑰餘範淵衊窪繭願遞膚 ) 达到	相似	2024-07-02
				Prolia
NCT05126784 (AVT03-GL-P01, GlobeNewswire) 人工标引	临床1期	-	-	AVT03	壓憲膚範獵鹽積窪繭構(醖壓繭製築餘淵繭鹹蓋) = met its primary endpoints 簾鹽選遞構鏇簾簾憲夢 (網積網淵鏇鏇齋淵憲襯 ) 达到更多	积极	2024-01-29