预约演示
更新于：2026-08-11
Ustekinumab biosimilar (Alvotech)
乌司奴单抗生物类似药（Alvotech）
更新于：2026-08-11
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 |
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
3
项与 乌司奴单抗生物类似药（Alvotech） 相关的临床试验JPRN-jRCTs041240172
Efficacy and Safety of Ustekinumab Biosimilar in Patients with Psoriasis Vulgaris
开始日期2025-01-22 |
申办/合作机构- |
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 ; Mortato, Edoardo ; Bianchi, Luca ; 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.
173
项与 乌司奴单抗生物类似药（Alvotech） 相关的新闻（医药）2026-08-10
REYKJAVIK,
ICELAND (August 10, 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 it will release its financial results for the first half of 2026 on Wednesday, August 19, 2026, after the U.S. market close.
The Company will also host a webcast with a live Q&A on Thursday, August 20, 2026, at 08:00 ET (12:00 GMT, 13:00 BST, 14:00 CEST).
To listen to the webcast, please register here:
H1 2026 webcast
To participate in the Q&A, please register here:
Q&A registration
Slides and other materials will be made available on
alvotech.com/financials
before the call.
For further information, contact:
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Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com
Investors
Dr. Balaji V Prasad (US)
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 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 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
.
For more information, please visit our
website
or follow us on social media on
LinkedIn
,
Facebook
,
Instagram
and
YouTube
.
None of the information on the Alvotech website shall be deemed part of this press release.
财报生物类似药
2026-07-29
REYKJAVIK, ICELAND (July 29, 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 the U.S Food and Drug Administration (FDA) has closed its inspection of the company’s manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA has confirmed the inspection classification of the manufacturing site is Voluntary Action Indicated (VAI). “This is an important milestone for Alvotech and reflects the significant work our teams have undertaken to further strengthen our quality systems and manufacturing operations,” said Lisa Graver, CEO of Alvotech. “With the conclusion of the FDA’s recent inspection, we are confident that the actions we have taken have effectively addressed the observations identified. We continue to work with the FDA to advance our recent Biologics Licence Applications towards approval.” Alvotech continues to advance its pipeline of biosimilar candidates. The company recently announced the resubmission of Biologics License Applications (BLAs) for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), and AVT06, Alvotech’s biosimilar to Eylea® (aflibercept), and the acceptance by the FDA of the submission of a BLA for AVT16, Alvotech’s proposed biosimilar to Entyvio® (vedolizumab) to the FDA in June 2026. Alvotech continues to work closely with health authorities worldwide to bring high-quality, affordable biologic medicines to patients. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V Prasad (US)Benedikt Stefansson (IS)alvotech.ir@alvotech.com About AlvotechAlvotech 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 13 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. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube. None of the information on the Alvotech website shall be deemed part of this press release. Use of trademarks Simponi® and Simponi Aria® are trademarks of Johnson & Johnson. Eylea® is a trademark of Regeneron Pharmaceuticals Inc. Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc.
生物类似药上市批准
2026-07-29
REYKJAVIK, Iceland, July 29, 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 the U.S. Food and Drug Administration (FDA) has closed its inspection of the company’s manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA has confirmed the inspection classification of the manufacturing site is Voluntary Action Indicated (VAI). “This is an important milestone for Alvotech and reflects the significant work our teams have undertaken to further strengthen our quality systems and manufacturing operations,” said Lisa Graver, CEO of Alvotech. “With the conclusion of the FDA’s recent inspection, we are confident that the actions we have taken have effectively addressed the observations identified. We continue to work with the FDA to advance our recent Biologics Licence Applications towards approval.” Alvotech continues to advance its pipeline of biosimilar candidates. The company recently announced the resubmission of Biologics License Applications (BLAs) for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), and AVT06, Alvotech’s biosimilar to Eylea® (aflibercept), and the acceptance by the FDA of the submission of a BLA for AVT16, Alvotech’s proposed biosimilar to Entyvio® (vedolizumab) to the FDA in June 2026. Alvotech continues to work closely with health authorities worldwide to bring high-quality, affordable biologic medicines to patients. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V Prasad (US)Benedikt Stefansson (IS)alvotech.ir@alvotech.com About AlvotechAlvotech 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 13 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. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube. None of the information on the Alvotech website shall be deemed part of this press release. Use of trademarks Simponi® and Simponi Aria® are trademarks of Johnson & Johnson. Eylea® is a trademark of Regeneron Pharmaceuticals Inc. Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc.
生物类似药上市批准
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
| KEGG | Wiki | ATC | Drug Bank |
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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
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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 |
|---|
临床3期 | 927 | (PsA STUDY 1) | 積願積觸憲餘蓋襯積觸(網鬱蓋蓋襯顧願繭艱積) = 糧憲醖獵觸壓簾膚鬱鬱 淵壓積鹽鏇鬱膚衊願齋 (壓鬱觸膚遞製艱範獵積 ) 更多 | 积极 | 2024-04-16 | ||
(PsA STUDY 1) | 積願積觸憲餘蓋襯積觸(網鬱蓋蓋襯顧願繭艱積) = 遞襯餘膚構襯艱窪鏇醖 淵壓積鹽鏇鬱膚衊願齋 (壓鬱觸膚遞製艱範獵積 ) 更多 | ||||||
临床3期 | 2,069 | Placebo (Ps STUDY 1 + Adult) | 夢醖構壓鏇醖襯夢製廠(範窪鏇鹽積鹹築夢餘鏇) = 壓窪構製鬱範願蓋鹹壓 憲淵窪齋築積壓積製範 (製獵顧獵構餘衊襯憲網 ) 更多 | 积极 | 2024-04-16 | ||
Ustekinumab 45 mg (Ps STUDY 1 + Adult) | 夢醖構壓鏇醖襯夢製廠(範窪鏇鹽積鹹築夢餘鏇) = 廠簾構齋窪齋積選膚壓 憲淵窪齋築積壓積製範 (製獵顧獵構餘衊襯憲網 ) 更多 | ||||||
临床3期 | 581 | 膚製獵窪壓築蓋膚顧選(觸網膚遞齋獵範鹹顧蓋) = 鑰鏇醖製夢壓醖鹹範遞 糧鹹積網範願鹹膚繭築 (餘鏇範鏇鹹觸壓衊醖廠 ) | 积极 | 2023-07-12 | |||
膚製獵窪壓築蓋膚顧選(觸網膚遞齋獵範鹹顧蓋) = 選鑰範淵鬱觸鏇齋繭觸 糧鹹積網範願鹹膚繭築 (餘鏇範鏇鹹觸壓衊醖廠 ) | |||||||
临床3期 | 581 | 選鹽膚廠艱構齋齋蓋繭(膚網餘觸憲齋繭壓淵艱) = 窪鹽膚糧製顧顧衊鬱選 鬱窪廠簾範顧膚醖製壓 (衊蓋簾衊鬱夢糧艱築憲 ) 更多 | - | 2023-03-17 | |||
Reference Ustekinumab | 選鹽膚廠艱構齋齋蓋繭(膚網餘觸憲齋繭壓淵艱) = 鑰齋積積積壓顧蓋網網 鬱窪廠簾範顧膚醖製壓 (衊蓋簾衊鬱夢糧艱築憲 ) 更多 |
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