乌司奴单抗生物类似药（Alvotech）(Ustekinumab biosimilar (Alvotech)) - 药物靶点：IL-12p40_在研适应症：活动性重度溃疡性结肠炎，活动性中度溃疡性结肠炎，银屑病_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

Ustekinumab Biosimilar、USTEKINUMAB-AEKN、乌司奴单抗生物类似药

+ [9]

靶点

IL-12p40

作用方式

抑制剂

作用机制

IL-12p40抑制剂(白细胞介素-12β亚基抑制剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [1]

在研适应症

活动性重度溃疡性结肠炎活动性中度溃疡性结肠炎银屑病+ [5]

非在研适应症-

原研机构-

在研机构

STADA Arzneimittel AGAlvotech

Fuji Pharma Co., Ltd.

+ [3]

非在研机构

Alvotech Swiss AG

权益机构

MedImpact Holdings, Inc.

Fuji Pharma Co., Ltd.

Alvotech hf

+ [7]

最高研发阶段批准上市

首次获批日期

日本 (2023-09-25),

银屑病关节炎斑块状银屑病

最高研发阶段(中国)无进展

特殊审评-

登录后查看时间轴

结构/序列

Sequence Code 143665H

来源: *****

Sequence Code 143874L

来源: *****

关联

2

项与乌司奴单抗生物类似药（Alvotech）相关的临床试验

NCT04930042

/ Completed临床3期

A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

开始日期2021-06-03

申办/合作机构

Alvotech Swiss AG

NCT04744363

/ Completed临床1期

Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara® in Healthy Adult Subjects

Protocol Title:
A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects
Short Title:
A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects
Rationale:
Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.

开始日期2021-05-25

申办/合作机构

Alvotech Swiss AG

[+1]

100 项与乌司奴单抗生物类似药（Alvotech）相关的临床结果

登录后查看更多信息

100 项与乌司奴单抗生物类似药（Alvotech）相关的转化医学

登录后查看更多信息

100 项与乌司奴单抗生物类似药（Alvotech）相关的专利（医药）

登录后查看更多信息

5

项与乌司奴单抗生物类似药（Alvotech）相关的文献（医药）

2026-06-01·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Efficacy and safety of ustekinumab biosimilars for treating moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis

Review

作者: Jia, Luyao ; Li, Zhenhua ; Liu, Chenyu ; Tang, Xin ; Ye, Yingying

To compare the efficacy and safety of different ustekinumab biosimilars for treating moderate-to-severe plaque psoriasis (PP), providing an evidence-based basis for clinical medication. We systematically searched randomized controlled trials on ustekinumab biosimilars for treating moderate-to-severe PP in adults from Embase, PubMed, Cochrane Library, and Web of Science. Stata 18.0 was utilized for data analysis. Nine studies were included, involving 4293 moderate-to-severe PP patients. 1) Ustekinumab biosimilars and the reference listed drug (RLD) ustekinumab-RP had no significant difference in the psoriasis area and severity index (PASI) improvement (P > 0.05), and the biosimilar CT-P43 was most effective in improving PASI at different time points. 2) For the dermatology life quality index, Bmab1200, AVT04 and CT-P43, had statistically significant differences from the RLD (P < 0.05). 3) The biosimilar CT-P43 was most effective in improving the Physician Global Assessment score, with the highest SUCRA value (99.8%). 4) The reduction of the body surface area and the treatment-emergent adverse event rate had no statistically significant difference from the RLD (P > 0.05). 5) The biosimilar CT-P43 and Bmab1200 demonstrated a lower probability of generating anti-drug antibodies, showing statistically significant differences from other biosimilars (P < 0.05). Ustekinumab biosimilars demonstrate comparable efficacy and safety to ustekinumab-RP for treating moderate-to-severe PP in adults. The biosimilar CT-P43 is more effective in improving short-term PASI. Due to limitations in the number and quality of included studies, more high-quality studies are required to validate these findings.

2024-07-01·Clinical Drug Investigation

AVT04: An Ustekinumab Biosimilar

Review

作者: Blair, Hannah A

AVT04 (Uzpruvo^®) is a biosimilar of the reference anti-interleukin (IL)-12 and IL-23 monoclonal antibody ustekinumab. It is approved in the EU for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn's disease as per the reference product. AVT04 has similar physicochemical characteristics to those of reference ustekinumab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate to severe chronic plaque psoriasis. AVT04 demonstrated clinical efficacy similar to that of reference ustekinumab in patients with moderate to severe chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT04 were similar to those of reference ustekinumab, and switching from reference ustekinumab to AVT04 had no impact on efficacy, safety or immunogenicity. The role of reference ustekinumab in the management of inflammatory diseases is well established and AVT04 provides an effective biosimilar alternative for patients requiring ustekinumab therapy.

2023-08-03·Expert opinion on biological therapy

Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis

Article

作者: Berti, Fausto ; Otto, Hendrik ; Stroissnig, Heimo ; Feldman, Steven R ; Haliduola, Halimu N ; Duijzings, Paul ; Leutz, Steffen ; Ruffieux, Ruth ; Reznichenko, Nataliya

BACKGROUND:

This study compared efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity between AVT04 and reference product (RP) ustekinumab (Stelara®) in patients with moderate-to-severe chronic plaque psoriasis (PsO).

PATIENTS AND METHODS:

This multicenter, double-blind, 52-week study randomized patients in 1:2 ratio to AVT04 or RP. At week 16, responsive patients (≥50% improvement in psoriasis area and severity index (PASI)) previously on AVT04 continued on AVT04, while those on RP were re-randomized 1:1 to switch to AVT04 or stay on RP. The primary endpoint was a percent improvement in PASI from baseline to week 12. Therapeutic equivalence was demonstrated if the confidence interval (CI) for the adjusted difference in means was contained within the equivalence margins; ±10% (90%CI).

RESULTS:

Of the 581 patients initially randomized (AVT04:RP, 194:387), 575 completed week 16 and 544 completed end of study visit. The percent PASI improvement for AVT04 vs RP was 87.3% vs 86.8% (CI: -2.14%, 3.01%); study met its primary endpoint. Efficacy, safety and PK profiles were comparable across treatment arms throughout the entire study duration, and the incidence of antibodies to ustekinumab had no clinically meaningful impact.

CONCLUSION:

This study demonstrates the therapeutic equivalence between AVT04 and RP in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.

TRIAL REGISTRATION:

NCT04930042; EudraCT Number: 2020-004,493-22.

191

项与乌司奴单抗生物类似药（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 项与乌司奴单抗生物类似药（Alvotech）相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D09214	乌司奴单抗生物类似药（Alvotech）	L04AC05	DB05679

研发状态

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
活动性重度溃疡性结肠炎	美国	Alvotech USA, Inc.	2024-10-18
活动性中度溃疡性结肠炎	英国	Genus Pharmaceuticals Ltd.	2024-03-26
银屑病	欧盟	Alvotech	2024-01-10
银屑病	冰岛	Alvotech	2024-01-10
银屑病	列支敦士登	Alvotech	2024-01-10
银屑病	挪威	Alvotech	2024-01-10
活动性中度克罗恩病	欧盟	STADA Arzneimittel AG	2024-01-05
活动性中度克罗恩病	冰岛	STADA Arzneimittel AG	2024-01-05
活动性中度克罗恩病	列支敦士登	STADA Arzneimittel AG	2024-01-05
活动性中度克罗恩病	挪威	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	欧盟	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	冰岛	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	列支敦士登	STADA Arzneimittel AG	2024-01-05
活动性重度克罗恩病	挪威	STADA Arzneimittel AG	2024-01-05
克罗恩病	加拿大	JAMP Pharma Corp.	2023-11-01
银屑病关节炎	日本	Fuji Pharma Co., Ltd.	2023-09-25
斑块状银屑病	日本	Fuji Pharma Co., Ltd.	2023-09-25

登录后查看更多信息

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


NCT04930042 (AVT04-GL-301, FDA_CDER) 人工标引	临床3期	斑块状银屑病	2,069	Placebo (Ps STUDY 1 + Adult)	餘襯憲艱壓鑰築壓築醖(觸願餘壓窪鹽餘簾壓壓) = 鑰鏇壓窪遞醖壓憲獵範鹹餘構糧鑰鹹鑰鏇衊醖 (齋膚窪鏇繭襯鏇願衊衊 ) 更多	积极	2024-04-16
				Ustekinumab 45 mg (Ps STUDY 1 + Adult)	餘襯憲艱壓鑰築壓築醖(觸願餘壓窪鹽餘簾壓壓) = 醖壓壓願糧積範繭鏇夢鹹餘構糧鑰鹹鑰鏇衊醖 (齋膚窪鏇繭襯鏇願衊衊 ) 更多
NCT04930042 (AVT04-GL-301, FDA_CDER) 人工标引	临床3期	银屑病关节炎	927	UstekinumabUstekinumab 45 mg (PsA STUDY 1)	憲鏇齋蓋壓製獵膚壓廠(鏇願糧淵蓋網鬱淵選獵) = 襯蓋觸網窪鹹遞顧憲網鹹簾蓋簾鏇壓膚醖窪繭 (膚願鬱鹹膚蓋衊觸獵製 ) 更多	积极	2024-04-16
				Ustekinumab 90 mgUstekinumab90 mg (PsA STUDY 1)	憲鏇齋蓋壓製獵膚壓廠(鏇願糧淵蓋網鬱淵選獵) = 衊艱餘觸網蓋鏇鏇願襯鹹簾蓋簾鏇壓膚醖窪繭 (膚願鬱鹹膚蓋衊觸獵製 ) 更多
NCT04930042 (Pubmed \| Expert Opin Biol Ther)	临床3期	斑块状银屑病	581	AVT04	憲衊鑰糧觸廠顧鏇餘觸(遞繭糧淵遞憲觸鏇選鹽) = 鬱醖夢淵襯醖齋選膚觸選廠選願壓網廠衊衊膚 (築製壓選壓顧艱憲範遞 )	积极	2023-07-12
				Reference product ustekinumab (Stelara®)	憲衊鑰糧觸廠顧鏇餘觸(遞繭糧淵遞憲觸鏇選鹽) = 蓋願醖選網鑰蓋醖窪構選廠選願壓網廠衊衊膚 (築製壓選壓顧艱憲範遞 )
NCT04930042 (AAD2023)	临床3期	银屑病	581	AVT04	選餘蓋鑰艱範簾鹹選積(鑰鬱鬱顧觸膚築構簾廠) = 醖範簾網鹹遞淵築淵憲淵鑰選顧觸鹹繭築獵鏇 (淵壓顧壓製願淵鬱糧夢 ) 更多	-	2023-03-17
				Reference Ustekinumab	選餘蓋鑰艱範簾鹹選積(鑰鬱鬱顧觸膚築構簾廠) = 築顧憲憲鑰憲窪構簾壓淵鑰選顧觸鹹繭築獵鏇 (淵壓顧壓製願淵鬱糧夢 ) 更多