预约演示
更新于：2026-02-02
Golimumab biosimilar (Alvotech)
戈利木单抗生物类似药（Alvotech）
更新于：2026-02-02
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Golimumab Biosimilar (Alvotech hf)、戈利木单抗生物类似药（Alvotech hf）、AVT-05 + [3] |
靶点 |
作用方式 抑制剂 |
作用机制 TNF-α抑制剂(肿瘤坏死因子α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 |
首次获批日期 日本 (2025-09-19), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 10217CDR2-L
当前序列信息引自: *****
Sequence Code 34550CDR3-L
当前序列信息引自: *****
Sequence Code 208354L
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Sequence Code 1694337H
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Sequence Code 13027041CDR2-H
当前序列信息引自: *****
Sequence Code 535237464CDR3-H
当前序列信息引自: *****
Sequence Code 559603504CDR1-L
当前序列信息引自: *****
Sequence Code 1167865419CDR1-H
当前序列信息引自: *****
关联
2
项与 戈利木单抗生物类似药（Alvotech） 相关的临床试验NCT05842213
Randomized, Double-blind, 2-arm Multicenter Study to Investigate the Efficacy, Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Subjects with Moderate to Severe Rheumatoid Arthritis
This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA).
The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.
The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.
开始日期2023-03-30 |
申办/合作机构 |
NCT05632211
A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants
Rationale:
Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.
Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.
开始日期2022-12-16 |
申办/合作机构 Alvotech Swiss AG [+1] |
100 项与 戈利木单抗生物类似药（Alvotech） 相关的临床结果
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100 项与 戈利木单抗生物类似药（Alvotech） 相关的转化医学
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100 项与 戈利木单抗生物类似药（Alvotech） 相关的专利（医药）
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2
项与 戈利木单抗生物类似药（Alvotech） 相关的文献（医药）2026-01-01·BIODRUGS
Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study
Article
作者: Wynne, Chris ; Lorch, Ulrike ; Ashdown, Thomas ; Rai, Masna ; Berti, Fausto ; Krantz, Edrich ; Leutz, Steffen ; Ruffieux, Ruth ; Vashishta, Laxmikant ; Luque, Monica ; Katial, Rohit ; Petrovic, Katarina ; Sattar, Abid
BACKGROUND:
AVT05, a recombinant, human, immunoglobulin G1қ monoclonal antibody, is a biosimilar to Simponi®.
OBJECTIVES:
The purpose of this study was to investigate the pharmacokinetic (PK) similarity, safety, tolerability, and immunogenicity between AVT05 and US-licensed and European Union (EU)-approved reference product (RP) golimumab (US-RP and EU-RP, respectively) in healthy adult participants.
METHODS:
Three hundred and thirty-six healthy male and female participants aged 18-55 years were randomized in a 1:1:1 ratio to AVT05, US-RP, or EU-RP. Participants received a single 50 mg/0.5 mL subcutaneous injection on Day 1 and were followed until Day 75. The primary PK endpoints were maximum serum concentration (Cmax) and area under the serum concentration-time curve from time zero to infinity (AUC0-inf). Pharmacokinetic similarity was demonstrated if the 90% confidence intervals for the geometric mean ratio for both AUC0-inf and Cmax were entirely contained within the prespecified margins of 80.00% and 125.00% for all six pairwise treatment comparisons. Secondary endpoints were additional PK parameters (area under the concentration-time curve from time zero to the last quantifiable concentration, time to Cmax, terminal elimination rate constant, terminal elimination half-life, apparent volume of distribution, and apparent clearance), safety, tolerability, and immunogenicity.
RESULTS:
Demographic and baseline characteristics were balanced between the treatment groups. The 90% confidence intervals for the geometric means ratio for the protein-adjusted primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (Cmax [AVT05/US-RP 89.45, 106.75; AVT05/EU-RP 92.33, 110.15; EU-RP/US-RP 88.64, 105.92]; AUC0-inf [AVT05/US-RP 94.35, 108.40; AVT05/EU-RP 98.46, 113.13; EU-RP/US-RP 89.36, 102.76]), supporting the demonstration of PK similarity. The secondary PK parameters were also comparable between the treatment arms. The mean serum golimumab concentrations through Day 75 post-dose were similar between treatment arms. Overall, 66.1% of participants experienced at least one treatment-emergent adverse event (TEAE) during the study period. The frequency of TEAEs was comparable across the treatment arms. The majority of TEAEs were mild to moderate in severity. There were two serious TEAEs reported (one [0.9%] each in AVT05 and EU-RP arms), neither of which was considered treatment related. Local administration site reactions were mild in severity and observed in 6.1%, 10.8%, and 5.5% of participants in the AVT05, EU-RP, and US-RP arms, respectively. Overall, 87 (75.7%), 92 (82.9%), and 89 (80.9%) participants in the AVT05, EU-RP, and US-RP arms, respectively, were anti-drug antibody positive; among those 66 (57.4%), 68 (61.3%), and 61 (55.5%) participants, respectively, were neutralizing antibody positive at least once during the study. The primary PK parameters (AUC0-inf and Cmax) were slightly lower in antidrug antibody-positive participants compared with antidrug antibody-negative participants.
CONCLUSIONS:
Following single-dose administration, the study supported a demonstration of PK similarity between AVT05 and EU-RP and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms.
CLINICAL TRIAL REGISTRATION:
The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05632211).
2026-01-01·BIODRUGS
Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study
Article
作者: Sattar, Abid ; Rai, Masna ; Zhelyazkova, Kristina ; Petrovic, Katarina ; Berti, Fausto ; Leutz, Steffen ; Bucknall, Richard ; Vashishta, Laxmikant ; Luque, Monica
BACKGROUND:
Golimumab is a safe and effective treatment for patients with rheumatoid arthritis. Biosimilars to the reference product (RP; Simponi®) may make treatment more accessible.
OBJECTIVES:
The aim of this study was to assess the efficacy of AVT05, a golimumab biosimilar, and RP, each used in combination with methotrexate, in participants with moderate-to-severe rheumatoid arthritis.
METHODS:
This was a 52-week, randomized, double-blind, two-arm, parallel-group, active-controlled study. Participants were randomized 1:1 to receive AVT05 (n = 251) or RP (n = 251), 50 mg subcutaneously once every 4 weeks to Week 12 inclusive. Randomization was stratified by the baseline Disease Activity Score-28 for Rheumatoid Arthritis using C-Reactive Protein (DAS28-CRP) [≤ 5.1 and > 5.1]. The primary endpoint was the change from baseline in DAS28-CRP at Week 16. At Week 16, responder participants (DAS28-CRP decreased by > 0.6 from baseline and disease activity DAS28-CRP ≤ 5.1) initially enrolled in the AVT05 arm continued to receive AVT05 every 4 weeks. Responder participants initially randomized to RP were re-randomized 1:1 to either continue receiving RP or switch to AVT05. Non-responders were discontinued from the study drug. Change from baseline in DAS28-CRP response criteria at weeks 4, 8, 12, 24, 32, 40, 48, and 52 and percentage of subjects achieving American College of Rheumatology 20/50/70 at weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 were assessed as secondary endpoints. Safety and immunogenicity endpoints were also assessed.
RESULTS:
At Week 16, the least squares mean (standard error) change from baseline in DAS28-CRP in AVT05 and RP was - 2.89 (0.058) and - 2.98 (0.058), respectively. The two-sided 95% confidence interval of the least squares mean difference (0.09; standard error 0.082) was entirely contained within the prespecified equivalence margin of - 0.6, 0.6 (- 0.07, 0.25), supporting a demonstration of comparative efficacy. Two sensitivity analyses (one [S1] without exclusion of any data because of intercurrent events, and one [S2] excluding data following intercurrent events or relevant protocol deviations) supported the robustness of the primary endpoint estimates (S1 95% confidence interval - 0.07, 0.25; S2 95% confidence interval - 0.07, 0.25). There were no notable differences in subgroup analyses. Secondary efficacy analyses were consistent with the primary endpoint, including in participants who switched treatments. Overall safety profiles showed no clinically meaningful differences between treatments, including in participants who switched treatments. Immunogenicity profiles were comparable between treatment arms at all timepoints, including in participants who switched treatments.
CONCLUSIONS:
Analysis of the change in DAS28-CRP from baseline to Week 16 supported the assessment of comparative efficacy between AVT05 and RP golimumab. Secondary efficacy endpoints were consistent with this, including in participants who switched. AVT05 had a safety and immunogenicity profile similar to that observed for RP at all timepoints, including in participants who switched treatments.
CLINICAL TRIAL REGISTRATION:
The trial is registered at ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT05842213) and the EU Clinical Trials Register (EudraCT Number: 2022-001825-63).
48
项与 戈利木单抗生物类似药（Alvotech） 相关的新闻（医药）2026-02-02
REYKJAVIK, Iceland, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has entered into supply and commercialization agreements with Sandoz covering multiple biosimilar candidates in Canada, and in Australia and New Zealand.
“These agreements with Sandoz further advance Alvotech’s strategy of securing commercial pathways for its biosimilars portfolio across global markets ahead of regulatory approval,” said Róbert Wessman, Chairman. “These partnerships reflect the strength of our integrated development and manufacturing platform and our ability to work with experienced regional partners to expand patient access while maintaining capital discipline.”
In Canada, the agreement covers one biosimilar candidate in ophthalmology supplied as a prefilled syringe for intravitreal injection. In Australia and New Zealand, the agreement encompasses three biosimilar candidates across immunology and gastroenterology, in multiple formulations. Sandoz will lead regulatory filings and commercial activities in the territories in close coordination with Alvotech. The collaboration is intended to support broad patient access following regulatory approvals and market launches across the region.
Under the agreements, Sandoz will be responsible for regulatory submissions, commercialization and distribution in the respective jurisdictions. Alvotech will retain responsibility for development, global clinical activities and manufacturing and will supply finished product to Sandoz under exclusive supply arrangements.
With a strong presence in Canada, Australia and New Zealand, Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably.
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 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.
Alvotech Forward-Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
生物类似药引进/卖出
2025-12-31
USD 100 million senior term loan facility with a 2-year maturity
Strengthens liquidity to support execution across Alvotech’s R&D pipeline and global product launches through 2026
Led by GoldenTree Asset Management
REYKJAVIK, Iceland, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced a USD 100 million senior term loan facility with maturity in December 2027 aimed at strengthening liquidity and supporting the execution of Alvotech’s strategic priorities in 2026.
“This USD 100 million financing underscores the long-term commitment of our financing partners at GoldenTree and their alignment with Alvotech’s strategy,” said Robert Wessman, Chairman and CEO of Alvotech. “Their support strengthens our ability to execute on our growth plans, invest in R&D, and deliver high-quality biosimilars to patients worldwide.”
With the transaction, led by GoldenTree Asset Management, Alvotech secures financing from investors who share the Company’s confidence in its ability to execute, and the scale, quality and commercial potential of its biosimilar product pipeline. Alvotech remains committed to advancing its R&D pipeline, which currently includes 30 products in development and ranks among the most valuable biosimilar portfolios in the industry. In parallel, the Company continues to expand its production capacity and strengthen its supply chain to support four new global product launches through 2026.
The transaction, a senior term loan facility in an aggregate principal amount of USD 100 million, bears an interest rate of 12.50%, payable monthly in cash, and has a maturity date of 2 years. The transaction replaces the Company’s previously disclosed working capital facility (ABL) and provides Alvotech with access to the full USD 100 million throughout the term of the loan. This structure offers enhanced operational flexibility.
This term loan facility follows the successful arrangement of a strategic refinancing transaction maturing in June 2029, also led by GoldenTree Asset Management, as announced in June 2024. In addition, Alvotech announced in June 2025 the repricing of its existing facility to an interest rate of SOFR plus 6.0% per annum, equivalent to approximately 9.8% based on the 30-day average SOFR rate of ~3.8%
Further reinforcing its capital structure, Alvotech recently announced the successful placing of USD 108 million senior unsecured convertible bonds due 2030. Together these transactions position the Company to maintain its leading position and investment into its biosimilar development pipeline.
For further information, please contact:
Media Benedikt Stefansson, VP Investor Relations and Global Communications Sarah Macleod, Head of Global Communications alvotech.media@alvotech.com
Investor Relations Balaji Prasad, Chief Strategy Officer Patrik Ling, VP Investor Relations Scandinavia (SE) Benedikt Stefansson, VP Investor Relations and Global Communications (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 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.
Alvotech Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
生物类似药
2025-12-22
Introduction of AVT05 supported by NHS England tender award in the United Kingdom REYKJAVIK, Iceland, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that launches are underway in Europe for Gobivaz® (golimumab), Alvotech’s biosimilar to Simponi® (golimumab), also known as AVT05 (prefilled syringe and autoinjector). Gobivaz is the first marketed biosimilar to Simponi worldwide. It is being commercialized exclusively in Europe by Alvotech’s partner, Advanz Pharma Holdco Limited (“Advanz Pharma”). In the United Kingdom, the introduction of Gobivaz is supported by a National Health Service (NHS) England tender award. This procurement decision provides a defined framework for adoption within NHS services and reflects the system’s focus on improving access to high quality biologic treatment options for immune mediated inflammatory diseases. Availability across EEA markets will progress in line with national pricing and reimbursement processes. “We welcome the introduction of Gobivaz into clinical practice across Europe following its approval as the first biosimilar to Simponi worldwide,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech. “Our biosimilar represents an important treatment option for patients, and the NHS England tender supports our aim of expanding the availability of high-quality biologic medicines.” Approval of Gobivaz was supported by comprehensive analytical, pre-clinical and clinical studies that demonstrated biosimilarity to the reference product. Gobivaz is available in the same presentations and dosage forms as Simponi and is manufactured at Alvotech’s facility in Iceland. For further information, please contact: MediaBenedikt Stefansson, VP Investor Relations and Global CommunicationsSarah Macleod, Head of Global Communicationsalvotech.media@alvotech.com Investor RelationsBalaji Prasad, Chief Strategy OfficerPatrik Ling, VP Investor Relations Scandinavia (SE)Benedikt Stefansson, VP Investor Relations and Global Communications (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 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. Alvotech Forward Looking StatementsCertain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 强直性脊柱炎 | 欧盟 | 2025-11-17 | |
| 强直性脊柱炎 | 冰岛 | 2025-11-17 | |
| 强直性脊柱炎 | 列支敦士登 | 2025-11-17 | |
| 强直性脊柱炎 | 挪威 | 2025-11-17 | |
| 非放射性轴性脊柱关节炎 | 欧盟 | 2025-11-17 | |
| 非放射性轴性脊柱关节炎 | 冰岛 | 2025-11-17 | |
| 非放射性轴性脊柱关节炎 | 列支敦士登 | 2025-11-17 | |
| 非放射性轴性脊柱关节炎 | 挪威 | 2025-11-17 | |
| 多关节型幼年特发性关节炎 | 欧盟 | 2025-11-17 | |
| 多关节型幼年特发性关节炎 | 冰岛 | 2025-11-17 | |
| 多关节型幼年特发性关节炎 | 列支敦士登 | 2025-11-17 | |
| 多关节型幼年特发性关节炎 | 挪威 | 2025-11-17 | |
| 活动性中度溃疡性结肠炎 | 欧盟 | 2025-11-17 | |
| 活动性中度溃疡性结肠炎 | 冰岛 | 2025-11-17 | |
| 活动性中度溃疡性结肠炎 | 列支敦士登 | 2025-11-17 | |
| 活动性中度溃疡性结肠炎 | 挪威 | 2025-11-17 | |
| 活动性重度溃疡性结肠炎 | 欧盟 | 2025-11-17 | |
| 活动性重度溃疡性结肠炎 | 冰岛 | 2025-11-17 | |
| 活动性重度溃疡性结肠炎 | 列支敦士登 | 2025-11-17 | |
| 活动性重度溃疡性结肠炎 | 挪威 | 2025-11-17 |
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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 | - | 336 | 醖衊夢簾窪積蓋簾衊膚(餘築繭選憲鬱糧遞鏇蓋) = The 90% confidence intervals for the geometric means ratio for the protein-adjusted primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (AUC0-inf [AVT05/US-RP 94.35, 108.40; AVT05/EU-RP 98.46, 113.13; EU-RP/US-RP 89.36, 102.76]) 糧選顧鹽製網衊餘糧壓 (繭襯積醖築顧艱鑰襯構 ) 更多 | 积极 | 2025-11-10 | ||
临床1期 | - | 336 | (AVT05 50mg s.c.) | 構衊網繭鑰廠蓋積衊遞(淵壓築製製艱獵廠範鏇) = 膚簾網夢廠鏇遞製蓋觸 繭糧襯顧壓憲齋襯獵醖 (艱願蓋簾鑰膚廠壓簾衊, 52) 更多 | - | 2025-05-28 | |
(EU Simponi 50mg s.c.) | 構衊網繭鑰廠蓋積衊遞(淵壓築製製艱獵廠範鏇) = 夢鏇範繭遞淵構構繭遞 繭糧襯顧壓憲齋襯獵醖 (艱願蓋簾鑰膚廠壓簾衊, 50) 更多 | ||||||
临床3期 | 502 | 積獵鹹憲鹹壓築衊憲窪(鑰遞壓淵積壓鹽壓獵鏇) = 夢簾醖鏇選鹹選齋鹹窪 構壓鹽鑰壓鬱構膚觸壓 (選獵願壓壓窪蓋願網願 ) 更多 | 积极 | 2024-11-10 | |||
Reference Golimumab | 積獵鹹憲鹹壓築衊憲窪(鑰遞壓淵積壓鹽壓獵鏇) = 夢範衊願糧鏇積顧網選 構壓鹽鑰壓鬱構膚觸壓 (選獵願壓壓窪蓋願網願 ) 更多 | ||||||
N/A | - | 製糧繭夢遞糧鏇範網製(醖襯範夢醖鹽選餘顧鹹) = met its primary endpoints 鹽鹽憲餘窪衊衊顧構網 (膚壓壓願簾簾鏇夢鏇鹽 ) 更多 | 积极 | 2023-11-29 | |||
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