预约演示
更新于：2026-06-03
Ustekinumab biosimilar (Alvotech)
乌司奴单抗生物类似药（Alvotech）
更新于：2026-06-03
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 + [6] |
靶点 |
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) |
在研适应症 |
非在研适应症- |
原研机构- |
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)无进展 |
特殊审评- |
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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
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 |
NCT04744363
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.
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
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100 项与 乌司奴单抗生物类似药（Alvotech） 相关的转化医学
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100 项与 乌司奴单抗生物类似药（Alvotech） 相关的专利（医药）
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6
项与 乌司奴单抗生物类似药（Alvotech） 相关的文献（医药）2026-04-01·Dermatology and Therapy
AVT04, a Biosimilar to Reference Product Ustekinumab, for the Treatment of Plaque Psoriasis: Insights from a Real-World Experience up to 28 Weeks
Article
作者: Talamonti, Marina ; Galluzzo, Marco ; Tofani, Lorenzo ; Marrapodi, Domenico ; Gneo, Valerio ; Bianchi, Luca ; Mortato, Edoardo ; Marcelli, Lorenzo ; Savastano, Lorenzo ; Ingrosso, Maria Rosa
INTRODUCTION:
This study aims to evaluate the real-life efficacy and safety of a biosimilar to reference product (RP) ustekinumab for the treatment of plaque psoriasis in different patient scenarios. The cohort included ustekinumab-switched patients, who switched from the RP to the biosimilar, and ustekinumab-naïve patients, never treated with ustekinumab. Ustekinumab-naïve patients were subdivided into bio-naïve (no prior biologic therapy) and bio-experienced (previous non-ustekinumab biologic therapy).
METHODS:
Adult patients with chronic plaque psoriasis treated with AVT04 were followed up to 28 weeks. Efficacy of the biosimilar was assessed by improvement of the Psoriasis Area Severity Index (PASI) 75, 90, and 100 responses from baseline to weeks 16 and 28. A cost-minimisation analysis over a 1-year time horizon was performed to estimate costs and potential savings with AVT04 versus RP across the Italian National Health Service (NHS).
RESULTS:
Throughout the observation period, a sustained improvement in PASI was observed in the overall cohort of 183 patients, encompassing both the ustekinumab-switched and ustekinumab-naïve groups. Within the ustekinumab-naïve group, a trend toward more favourable PASI 75/90/100 responses was observed in bio-naïve patients compared to bio-experienced patients. By 28 weeks of treatment, a higher proportion of bio-naïve patients compared to the bio-experienced group achieved PASI 75 (72.7% vs. 56.2%), PASI 90 (72.7% vs. 50.0%), and PASI 100 (54.5% vs. 37.5%), respectively (p > 0.05). No adverse events were reported during the study. Furthermore, the cost-minimisation analysis suggested that compared to the RP, AVT04 has the potential to generate approximately €5200 in annual savings per patient for the Italian NHS, representing around €20 million in nationwide savings.
CONCLUSION:
AVT04 biosimilar shows consistent efficacy results in both ustekinumab-switching and ustekinumab-naïve patients, supporting its integration into real-world practice as an effective and cost-saving therapeutic option. Further studies are warranted to confirm and expand these preliminary findings across a broader bio-naïve cohort.
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.
165
项与 乌司奴单抗生物类似药（Alvotech） 相关的新闻（医药）2026-06-03
REYKJAVIK, Iceland, June 02, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Alvotech's Founder and Executive Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in June as follows:
Jefferies Global Healthcare Conference in New York –
fireside chat on Thursday, June 4, 2026 at 9:20 am ET
Goldman Sachs 47
th
Annual Global Healthcare Conference in Miami –
fireside chat Monday, June 8, 2026 at 8:40 am ET
UBS Virtual Generics and Biosimilars Day
– fireside chat on Wednesday, June 10, 2026 at 10:30 am ET
The live audio webcasts will be available to investors and the general public and can be accessed in the Investors Section of Alvotech’s website under
News and Events – Events and Presentations
. After the event, 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
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
investor portal
, and our
website
or follow us on social media on
LinkedIn
,
Facebook
,
Instagram
and
YouTube
.
2026-06-02
REYKJAVIK, ICELAND (June 2, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Alvotech's Founder and Executive Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in June as follows:
Jefferies Global Healthcare Conference in New York – fireside chat on Thursday, June 4, 2026 at 9:20 am ET (13:20 GMT)
Goldman Sachs 47th Annual Global Healthcare Conference in Miami – fireside chat Monday, June 8, 2026 at 8:40 am ET (12:40 GMT)
UBS Virtual Generics and Biosimilars Day – fireside chat on Wednesday, June 10, 2026 at 10:30 am ET (14:30 GMT)
The live audio webcasts will be available to investors and the general public and can be accessed in the Investors Section of Alvotech’s website under News and Events – Events and Presentations. After the event, 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 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 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
2026-06-01
REYKJAVIK,
ICELAND (June 1, 2026)
— Alvotech (Nasdaq: ALVO) and Islandsbanki have renewed and amended their existing market making agreement. According to the agreement, Islandsbanki places bids and offers for ALVO shares trading on the Nasdaq Iceland Main Market (the “Exchange”) for a minimum amount with a fixed spread between the bid and offer price.
The objective of the market-making agreement is to increase trade in Alvotech’s shares, liquidity and transparent price formation.
As a market maker, Islandsbanki will post bid and ask quotes on the Exchange with an aggregate market value of at least ISK 8 million prior to the start of daily trading. Both the bid and ask quotes shall be refreshed as soon as possible but no later than 15 minutes after being executed in full. Islandsbanki aims to maintain more than one bid and/or ask quote for Alvotech’s shares such that the total market value of outstanding quotes is at least ISK 8 million at all times, but the bank is not obligated to maintain multiple bid or ask quotes. Islandsbanki also reserves the right to post additional bid and ask quotes even if existing quotes remain unexecuted.
The maximum spread between bid and ask quotes is 2.5%, calculated as the volume weighted average of the bid and ask quotes for Alvotech’s shares posted by Islandsbanki as market maker at any given time. The daily net volume of trades by Islandsbanki as a market maker in Alvotech’s shares shall be limited to ISK 16 million. This amount is calculated as the difference between bids and asks by Islandsbanki that have been executed in full. When the maximum amount is reached, Islandsbanki is under no further obligation during that day to post either a bid or ask quote, depending on which side has been filled. Once a quote on the opposite side is executed and the daily net volume falls below the ISK 16 million mark, the market maker’s obligation to post bid and ask quotes is restored.
The amended agreement was executed on May 29, 2026, and has no fixed term. Each party has the right to terminate the agreement by giving a 7-day prior notice.
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
. 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
.
ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com
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
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外链
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 活动性中度溃疡性结肠炎 | 美国 | 2024-10-18 | |
| 活动性重度溃疡性结肠炎 | 美国 | 2024-10-18 | |
| 银屑病 | 欧盟 | 2024-01-10 | |
| 银屑病 | 冰岛 | 2024-01-10 | |
| 银屑病 | 列支敦士登 | 2024-01-10 | |
| 银屑病 | 挪威 | 2024-01-10 | |
| 活动性中度克罗恩病 | 欧盟 | 2024-01-05 | |
| 活动性中度克罗恩病 | 冰岛 | 2024-01-05 | |
| 活动性中度克罗恩病 | 列支敦士登 | 2024-01-05 | |
| 活动性中度克罗恩病 | 挪威 | 2024-01-05 | |
| 活动性重度克罗恩病 | 欧盟 | 2024-01-05 | |
| 活动性重度克罗恩病 | 冰岛 | 2024-01-05 | |
| 活动性重度克罗恩病 | 列支敦士登 | 2024-01-05 | |
| 活动性重度克罗恩病 | 挪威 | 2024-01-05 | |
| 克罗恩病 | 加拿大 | 2023-11-01 | |
| 银屑病关节炎 | 日本 | 2023-09-25 | |
| 斑块状银屑病 | 日本 | 2023-09-25 |
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临床结果
临床结果
适应症
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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 |
|---|
临床3期 | 927 | (PsA STUDY 1) | 願觸顧築觸廠齋鏇餘糧(簾觸網顧壓鏇艱簾艱獵) = 鬱積襯鹽範鑰窪淵廠膚 齋廠醖築憲壓鏇壓鑰鹹 (憲簾獵艱衊顧築觸製膚 ) 更多 | 积极 | 2024-04-16 | ||
(PsA STUDY 1) | 願觸顧築觸廠齋鏇餘糧(簾觸網顧壓鏇艱簾艱獵) = 遞觸觸獵選觸築製顧積 齋廠醖築憲壓鏇壓鑰鹹 (憲簾獵艱衊顧築觸製膚 ) 更多 | ||||||
临床3期 | 2,069 | Placebo (Ps STUDY 1 + Adult) | 醖鬱窪醖糧鏇衊製鑰鏇(醖襯鏇遞構鏇淵膚夢鏇) = 淵顧襯鹽醖艱築鏇獵鬱 網積壓製齋膚觸壓襯齋 (製製壓鏇鏇選廠襯願夢 ) 更多 | 积极 | 2024-04-16 | ||
Ustekinumab 45 mg (Ps STUDY 1 + Adult) | 醖鬱窪醖糧鏇衊製鑰鏇(醖襯鏇遞構鏇淵膚夢鏇) = 積簾膚鹽襯廠壓淵醖廠 網積壓製齋膚觸壓襯齋 (製製壓鏇鏇選廠襯願夢 ) 更多 | ||||||
临床3期 | 581 | 簾襯築觸願膚壓繭艱築(遞鹹糧鹹鬱觸繭鬱醖糧) = 願選築範夢蓋鹽憲顧積 選夢網簾鹹繭鹽壓艱襯 (廠顧衊鏇積觸遞製積夢 ) | 积极 | 2023-07-12 | |||
簾襯築觸願膚壓繭艱築(遞鹹糧鹹鬱觸繭鬱醖糧) = 鹽醖簾觸觸艱願顧遞繭 選夢網簾鹹繭鹽壓艱襯 (廠顧衊鏇積觸遞製積夢 ) | |||||||
临床3期 | 581 | 選獵憲簾艱鑰膚簾繭淵(願鏇糧餘淵範廠鹹網艱) = 鏇獵簾襯糧製壓繭顧衊 網艱鏇餘窪鹽齋積願淵 (糧淵構製選衊築餘構鏇 ) 更多 | - | 2023-03-17 | |||
Reference Ustekinumab | 選獵憲簾艱鑰膚簾繭淵(願鏇糧餘淵範廠鹹網艱) = 積製鑰襯艱膚淵簾鹽鑰 網艱鏇餘窪鹽齋積願淵 (糧淵構製選衊築餘構鏇 ) 更多 |
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