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

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

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).

项与地舒单抗生物类似药（ Alvotech）相关的新闻（医药）

2026-03-30

·investors.alvotech.com

Alvotech files Annual Report with the SEC

REYKJAVIK, ICELAND (March 30, 2026) — Alvotech (NASDAQ: ALVO) (the “Company”) has filed its Annual Report 2025 on Form 20-F for the financial year 2025 with the U.S. Securities and Exchange Commission (SEC), incorporating by reference parts of the Alvotech Annual Report 2025. The report is available on the SEC’s website, www.sec.gov, as well as in the investor relations section of Alvotech’s website at https://investors.alvotech.com/financials. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad (US) Patrik Ling (SE) Benedikt Stefansson (IS) 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 biosimilars 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 investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.

生物类似药

2026-03-30

·investors.alvotech.com

Alvotech Publishes 2025 Annual Report

REYKJAVIK, ICELAND (March 30, 2026) — Alvotech (NASDAQ: ALVO) (the “Company”) has published its Annual Report for 2025. The report is available in the investor relations section of Alvotech’s website at: https://investors.alvotech.com/financials and is attached to this announcement in PDF and iXBRL formats. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad (US) Patrik Ling (SE) Benedikt Stefansson (IS) 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 biosimilars 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 investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube. Attachments Alvotech Consolidated Financial Statements FY 2025 222100DCZBOWV5DZ8372-2025-12-31-1-en

生物类似药

2026-03-21

·雪球

Alvotech2025财年四季报业绩会议总结

一、开场介绍会议时间：2025年第四季度主持人说明：介绍会议目的为公布2025年全年及第四季度财务业绩，相关材料已发布于投资者门户网站；提示可能包含前瞻性陈述，存在风险和不确定性。管理层发言摘要：RobertWessman（创始人、董事长兼执行董事长）：2025年是关键一年，巩固全球领先生物类似药开发商地位，解决FDA对雷克雅未克生产设施的监管意见，推进30种生物类似药管线，财务表现增长（总收入增长20%，调整后EBITDA增长27%），LisaGraver接任首席执行官，公司进入运营执行和商业规模新阶段。二、财务业绩分析核心财务数据全年收入：5.93亿美元（同比增长21%），产品收入与许可收入各占50%；全年调整后EBITDA：1.37亿美元（同比增长27%），利润率23%；第四季度收入：1.73亿美元（同比增长13%），其中许可收入占75%；第四季度调整后EBITDA：6900万美元，利润率40%；产品利润率：第四季度为-37%，全年运营现金流首次为正（700万美元）；年终现金余额：1.72亿美元，得益于第四季度融资（1.08亿美元可转换债券+1亿美元高级定期贷款）。关键驱动因素收入增长主要由许可收入推动，得益于开发进展及美国以外新launch相关的性能里程碑；产品销售疲软受订单时间安排和为支持即将到来的launch进行的计划设施升级影响；毛利率受许可收入占比高推动（全年61%，第四季度66%）。三、业务运营情况分业务线表现现有产品：修美乐生物类似药（AVT02）在美国市场份额约9%，为细分市场第二大且增长最快的生物类似药之一；喜达诺生物类似药（AVT04）在美国生物类似药市场占40%份额，欧洲Uzpruvo在生物类似药细分市场占超20%份额；新获批产品：AVT03（地诺单抗）、AVT05（类克）、AVT06（阿柏西普）在欧洲、英国、日本等市场获批并launch，其中AVT05在欧洲、日本为首个获批的类克生物类似药，AVT06在日本为首个获批的阿柏西普生物类似药。市场拓展商业合作伙伴：与梯瓦（美国launchSelarsdi）、AdvanzPharma（Cimzia项目）、Dr.Reddy's（Keytruda项目）、山德士（扩大市场覆盖）等合作，全球商业网络持续扩展；地域覆盖：在欧洲、英国、日本、加拿大等市场推进产品批准和launch，美国市场等待FDA重新提交申请后的批准。研发投入与成果管线进展：30种生物类似药在研，覆盖全球销售额超1.85亿美元的市场；Entyvio生物类似药关键药代动力学研究结果积极，预计2026年晚些时候提交监管申请；Keytruda生物类似药预计2028年提交上市申请；监管策略：预见FDA生物类似药开发draft指南变化，调整开发战略，减少对大型疗效试验的依赖，降低成本和时间。运营效率生产设施：解决FDA对雷克雅未克工厂的监管意见，实施全面质量改进计划，预计2026年第二季度重新提交申请；推进关键产品双重来源生产，评估美国CMO合作，减少单一基地依赖；产能扩张：收购Ivers-Lee增强组装包装能力，收购Xbrane研发团队增强工艺开发，雷克雅未克工厂增加新原料药和制剂生产套件。四、未来展望及规划短期目标（2026年）财务预期：收入6.5亿-7亿美元（两位数增长），调整后EBITDA1.8亿-2.2亿美元（下限假设无美国launch收入）；战略重点：推进美国FDA申请重新提交（第二季度），实现年底前获批；扩大已批准产品在欧洲、日本等市场的商业launch；完成关键产品双重来源生产合作。中长期战略行业趋势：生物类似药市场长期驱动因素强劲，全球药品销售额40%来自生物制剂，未来十年超100种生物制剂失去专利保护；公司定位：利用FDA新指南降低研发成本，保持行业领先的管线开发速度（每两个月启动一个新项目）；投资方向：扩展制造足迹（美国为重点），加强供应链弹性，深化全球商业合作伙伴关系。五、问答环节要点FDA批准进展问：FDA补救计划完成情况及重新提交后获批信心？答：已完成补救措施，正收集改进有效性信息，预计2026年第二季度重新提交；FDA可能进行额外检查，但将提交全面回应以减少检查需求。财务指导细节问：2026年指导范围（6.5亿-7亿美元）是否包含美国新launch收入？答：下限未包含美国launch收入，上限包含许可收入和产品销售增长；指导基于已获批产品在欧美日等市场的launch势头。制造扩张与成本问：双重来源生产的时间安排、成本及对研发费用的影响？答：上半年确定合作方，成本在预期研发支出范围内，不额外增加资本支出；目标是增强供应弹性和商业合作伙伴价值。竞争风险应对问：如何减轻生物类似药市场竞争风险？答：通过先发优势（开发速度、早期监管策略）、知识产权布局、与强商业伙伴合作（如梯瓦、STADA）快速渗透市场，选择高壁垒项目。产品销售趋势问：修美乐生物类似药（AVT02）销售疲软是否为信号？答：季度波动属B2B业务正常现象，2025年美国市场份额达9%，预计2026年随品牌药侵蚀（生物类似药占比55%）持续增长；产品毛利率2026年将回升。六、总结发言管理层表示：Alvotech已建立整合的生物类似药平台，2025年扩展平台同时加强运营基础；未来优先事项：推进产品在全球市场的批准和商业化，关注运营卓越、效率与合规，扩展制造足迹和管线，利用行业趋势抓住生物类似药机遇；强调团队将继续执行战略，打造全球领先的生物类似药公司。查看业绩会议全文

生物类似药财报

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
-	-	M05BX04	-

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
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	STADA Arzneimittel AG	2025-11-17
自发性骨折	欧盟	Reddy Holding GmbH	2025-11-17
自发性骨折	冰岛	Reddy Holding GmbH	2025-11-17
自发性骨折	冰岛	STADA Arzneimittel AG	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	STADA Arzneimittel AG	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	STADA Arzneimittel AG	2025-09-18
骨质疏松性骨折	申请上市	欧盟	Reddy Holding GmbH	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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分期

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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)	鹽壓憲鑰壓廠淵衊願鏇(網鏇淵選願鬱憲積餘觸) = 壓鏇糧夢鹹願鬱選積網醖範糧齋憲積蓋遞選鬱 (糧構齋鏇襯製壓壓選衊, 34) 更多	-	2025-05-15
				Denosumab (Active Comparator Xgeva 120mg)	鹽壓憲鑰壓廠淵衊願鏇(網鏇淵選願鬱憲積餘觸) = 築衊鬱蓋鬱積遞糧觸願醖範糧齋憲積蓋遞選鬱 (糧構齋鏇襯製壓壓選衊, 32) 更多
NCT05876949 (AVT03-GL-P03, GlobeNewswire) 人工标引	临床1期	绝经期后骨质疏松	208	AVT03	齋製鬱壓鹹繭製構憲艱(積鏇蓋襯淵醖廠艱蓋獵) = 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. 鬱艱夢製醖膚艱齋膚顧 (範憲鏇遞鑰壓繭齋遞顧 ) 达到	相似	2024-07-02
				Prolia
NCT05126784 (AVT03-GL-P01, GlobeNewswire) 人工标引	临床1期	-	-	AVT03	齋網膚繭鹽鏇網壓製艱(選製艱鏇鬱積廠膚觸襯) = met its primary endpoints 醖鬱鹹壓膚憲夢鹹膚網 (願餘窪襯鏇簾襯鏇範獵 ) 达到更多	积极	2024-01-29