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更新于：2026-08-28
Adalimumab biosimilar(Alvotech)
阿达木单抗生物类似药 (Alvotech)
更新于：2026-08-28
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Sequence Code 26792L
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Sequence Code 88699H
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关联
10
项与 阿达木单抗生物类似药 (Alvotech) 相关的临床试验NCT05913817
The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.
NCT04453137
Multicenter, Double-Blind, Randomized, Parallel-group, Study Evaluating PK, Efficacy, Safety, and Immunogenicity in Patients With Plaque Psoriasis Receiving Humira® or AVT02 Followed by a Safety Extension Phase of AVT02
NCT04224194
Assessment of Real-life Patient Handling Experience of AVT02 Administered Subcutaneous With an Auto-Injector in Patients With Moderate to Severe Active RA
100 项与 阿达木单抗生物类似药 (Alvotech) 相关的临床结果
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100 项与 阿达木单抗生物类似药 (Alvotech) 相关的转化医学
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100 项与 阿达木单抗生物类似药 (Alvotech) 相关的专利（医药）
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10
项与 阿达木单抗生物类似药 (Alvotech) 相关的文献（医药）2026-06-01Rheumatology and Therapy
Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi®) Across Multiple Indications (EASE PAIN)
Article
作者: Vender, Ronald B ; Narula, Neeraj ; Afif, Waqqas ; Thorne, Carter ; Steinhart, A Hillary ; Lynde, Charles W ; Bessette, Louis ; Shahrokh, Dara K ; Rao, Jaggi ; Sutton, Evelyn
INTRODUCTION:
Injection site pain (ISP) is a frequent concern with subcutaneous adalimumab therapy and may negatively affect treatment adherence and patient satisfaction. AVT02 is a high-concentration, low-volume (40 mg/0.4 mL), citrate-free biosimilar of reference product (RP) adalimumab (40 mg/0.8 mL; citrate-containing). The EASE PAIN study evaluated the real-world impact of switching from adalimumab RP or another biosimilar to AVT02 on ISP and patient-reported outcomes over 180 days.
METHODS:
The EASE PAIN study (NCT05913817) was a national, observational, prospective phase IV study with a 6-month follow-up. The study enrolled Canadian patients with gastrointestinal conditions (Crohn's disease [CD], ulcerative colitis [UC]), rheumatological conditions (rheumatoid arthritis [RA], ankylosing spondylitis [AS], psoriatic arthritis [PsA]) or dermatological conditions (hidradenitis suppurativa [HS], psoriasis [PsO]). Participants were eligible if their treating physician had already decided to switch them from a high-volume RP or alternative adalimumab biosimilar to low-volume AVT02. The study assessed ISP measured via the Visual Analog Scale (VAS), adherence via the compliance rate, patient satisfaction and perception of change in pain via the Likert scale, injection site reactions (ISR) via a checklist (bleeding, burning, erythema, itching, soreness, swelling), quality of life based on EQ-5D-5L, and disease activity via the patient and physician global assessment scores for participants up to day 180 after switching. Healthcare utilization was measured as per the frequency, type, and volume of medical services accessed.
RESULTS:
The intention-to-treat (ITT) population comprised 324 participants. Following the first administration of AVT02, mean ISP VAS scores improved by - 19.9 ± 26.1 mm compared with baseline. Adherence rate was 93.4% overall. More than 74.4% of patients reported being mostly or completely satisfied with treatment, and 76.9% of the participants perceived AVT02 as less painful as measured by the 5-Likert scale. Moreover, a lower number of patients experienced ISRs after their first dose of AVT02 (36 patients; 12.4%) compared with their last dose of high-volume adalimumab (124 patients; 42.3%). Quality-of-life scores remained stable throughout follow-up. No clinically meaningful changes were observed in disease activity or healthcare utilization.
CONCLUSIONS:
In this real-world Canadian study, switching from adalimumab RP or alternative biosimilar to AVT02 was associated with reductions in ISP and reactions while maintaining high adherence, patient satisfaction, quality of life, and disease control across multiple indications.
TRIAL REGISTRATION:
This trial is registered with ClinicalTrials.gov: NCT05913817.
2024-01-01Immunotherapy advances
Ex vivo comparative immunogenicity assessment (EVCIA) to determine relative immunogenicity in chronic plaque psoriasis in participants receiving Humira® or undergoing repeated switches between Humira® and AVT02
Article
作者: Guenzi, Eric ; Reznichenko, Nataliya ; Mazy, Aurélie ; Schockaert, Jana ; Haliduola, Halimu N ; Richter, Kathleen ; Berti, Fausto
Summary:
Immunogenicity against biologic medicines is ubiquitous, and it is traditionally measured by the final humoral response. However, the onset of a sustained immunogenic response begins at the cellular level with activation of T cells and maturation of naïve B cells into plasma cells. Ex vivo comparative immunogenicity assessment (EVCIA) of cellular immunogenicity in participants with moderate-to-severe chronic plaque psoriasis in the AVT02-GL-302 study, who received either reference product (RP) alone (non-switching arm) or switched between RP and AVT02 (switching arm) after 1:1 randomization at week 12. Peripheral blood mononuclear cells (PBMCs) were collected and cryopreserved from 28 participants at: baseline (before treatment) (week 1); pre-randomization (week 12); and week 16 and week 28 in both switching and non-switching arms. PBMCs were thawed and re-exposed to either medium alone (negative control), RP, AVT02, keyhole limpet hemocyanin (KLH) (positive control), RP+KLH, or AVT02+KLH. Samples from 10 participants (predetermined average cell viability of 75% across all timepoints) from each arm were analyzed for cytokine release after 24 hours and for Th-cell proliferation, 6 days post-seeding. Until week 28, cytokine release and Th-cell proliferation was similar at all time points in both switching and non-switching arms. Overall cellular immune response was elevated post-KLH re-exposure at all timepoints. The comparable ex vivo cellular immunogenicity between switching and non-switching arms complements the confirmation of interchangeability in the main study. Given the sensitivity of novel EVCIA, detecting cellular immunogenicity could be a potential outcome in predicting the immunogenicity of biologic medicines.
2024-01-01Therapeutic advances in chronic disease
The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira
Review
作者: Berger, Verena ; Ómarsdóttir, Sesselja ; McClellan, Joseph E. ; Roy, Nivedita ; Michel, Cecilia ; Berti, Fausto
The development of a biosimilar is based on comparative structural, physicochemical, functional and clinical assessments. The sum of these analyses encompasses the ‘totality of evidence’, which demonstrates no clinically meaningful differences between the biosimilar and the reference product (RP). Once biosimilarity has been established, provided there is suitable scientific justification, clinical data may be extrapolated to other indications of the RP. AVT02 has been developed as a biosimilar to high-concentration, low-volume Humira (adalimumab), an anti-tumour necrosis factor-alpha monoclonal antibody approved for various chronic inflammatory indications. The totality of evidence for AVT02 is described, supporting its approval as an adalimumab biosimilar for all approved indications globally. Analytical similarity assessments using mass spectrometry methods demonstrated identical amino acid sequences for AVT02 and the RP, with high similarity in terms of primary structure, post-translational modifications and higher-order structural attributes. The mechanism of action was assessed by various cell-based potency assays and binding assays, and the results demonstrated that AVT02 is highly similar to the RP. No clinically meaningful differences in terms of purity, potency and safety were observed, and minor differences in a few physiochemical attributes did not impact the in vitro biologic activity and were not considered clinically relevant. Clinical similarity was demonstrated by comparing the pharmacokinetic, efficacy, safety and immunogenicity profiles of AVT02 with those of the RP. Clinical studies supported similar pharmacokinetic and comparable immunogenicity profiles between AVT02 and the RP in healthy participants and participants with moderate-to-severe chronic plaque psoriasis, with no new safety signals detected. The totality of evidence described demonstrates the biosimilarity of AVT02 to the RP, thereby fulfilling the scientific and regulatory requirements for AVT02 as a high-concentration biosimilar for the treatment of chronic plaque psoriasis and all approved indications of the RP.
181
项与 阿达木单抗生物类似药 (Alvotech) 相关的新闻（医药）100 项与 阿达木单抗生物类似药 (Alvotech) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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| - | 阿达木单抗生物类似药 (Alvotech) |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 多关节型幼年特发性关节炎 | 加拿大 | 2022-01-10 | |
| 活动性中度克罗恩病 | 欧盟 | 2021-11-15 | |
| 活动性中度克罗恩病 | 冰岛 | 2021-11-15 | |
| 活动性中度克罗恩病 | 列支敦士登 | 2021-11-15 | |
| 活动性中度克罗恩病 | 挪威 | 2021-11-15 | |
| 活动性重度克罗恩病 | 欧盟 | 2021-11-15 | |
| 活动性重度克罗恩病 | 冰岛 | 2021-11-15 | |
| 活动性重度克罗恩病 | 列支敦士登 | 2021-11-15 | |
| 活动性重度克罗恩病 | 挪威 | 2021-11-15 | |
| 全葡萄膜炎 | 欧盟 | 2021-11-15 | |
| 全葡萄膜炎 | 冰岛 | 2021-11-15 | |
| 全葡萄膜炎 | 列支敦士登 | 2021-11-15 | |
| 全葡萄膜炎 | 挪威 | 2021-11-15 | |
| 中间葡萄膜炎 | 欧盟 | 2021-11-15 | |
| 中间葡萄膜炎 | 冰岛 | 2021-11-15 | |
| 中间葡萄膜炎 | 列支敦士登 | 2021-11-15 | |
| 中间葡萄膜炎 | 挪威 | 2021-11-15 | |
| 后葡萄膜炎 | 欧盟 | 2021-11-15 | |
| 后葡萄膜炎 | 冰岛 | 2021-11-15 | |
| 后葡萄膜炎 | 列支敦士登 | 2021-11-15 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 自身炎症性疾病 | 申请上市 | 美国 | 2022-02-28 | |
| 慢性大斑块银屑病 | 临床3期 | 美国 | 2019-02-20 | |
| 慢性大斑块银屑病 | 临床3期 | 爱沙尼亚 | 2019-02-20 | |
| 慢性大斑块银屑病 | 临床3期 | 波兰 | 2019-02-20 | |
| 慢性大斑块银屑病 | 临床3期 | 乌克兰 | 2019-02-20 | |
| 炎症 | 临床1期 | 澳大利亚 | 2019-03-20 | |
| 炎症 | 临床1期 | 新西兰 | 2019-03-20 |
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临床结果
临床结果
适应症
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临床4期 | 324 | 鹹窪網鬱醖壓醖窪網範(範夢簾窪鏇選範遞鏇鹹) = 觸鹽繭網願醖淵艱繭積 衊膚鹹網襯遞構願積壓 (構遞鬱鹽願築鹽積製壓 ) 更多 | 积极 | 2026-06-11 | |||
临床4期 | 324 | 築願鏇積鹹艱鬱願鬱齋(鏇鬱憲繭繭簾製淵選觸) = 衊餘艱餘鹽衊選構廠積 鹽淵艱壓簾築夢膚鬱簾 (醖餘夢蓋簾遞衊製構積 ) 更多 | 积极 | 2026-04-10 | |||
临床4期 | 287 | 築網廠壓壓蓋膚築願鏇(淵糧顧積糧遞齋積襯築) = 鹹窪鏇衊鹽繭醖積壓簾 齋遞壓簾鹽簾顧觸製夢 (淵窪淵獵鹹顧觸遞壓壓 ) 更多 | 积极 | 2025-03-07 | |||
临床3期 | 107 | AVT02 with autoinjector (AI) | 鹹積衊簾廠鏇蓋壓襯淵(願齋齋壓獵衊鹹築蓋鹽) = 齋積願願鹹夢築齋鬱鹽 觸鹽鬱鹹夢蓋蓋膚夢簾 (獵壓鏇鑰糧選顧獵範淵 ) 更多 | - | 2022-06-01 | ||
AVT02 with pre-filled syringe (ALVOPAD-PEN) | 鹹積衊簾廠鏇蓋壓襯淵(願齋齋壓獵衊鹹築蓋鹽) = 繭構獵積憲積觸願獵願 觸鹽鬱鹹夢蓋蓋膚夢簾 (獵壓鏇鑰糧選顧獵範淵 ) 更多 | ||||||
临床3期 | 413 | 獵餘膚觸餘蓋鏇艱夢蓋(蓋糧齋鹹夢膚糧願醖衊) = 製蓋鑰餘廠醖築蓋廠鬱 獵衊選顧顧繭鏇製膚淵 (觸糧艱餘壓窪衊構獵膚 ) 更多 | 相似 | 2021-11-01 | |||
獵餘膚觸餘蓋鏇艱夢蓋(蓋糧齋鹹夢膚糧願醖衊) = 遞淵遞製鬱醖餘餘淵積 獵衊選顧顧繭鏇製膚淵 (觸糧艱餘壓窪衊構獵膚 ) 更多 | |||||||
N/A | 2,798 | 餘築願築構窪鹽餘願糧(範膚艱觸艱衊夢獵膚壓) = 鹹繭廠鏇觸鑰憲襯醖網 觸繭積餘夢網淵遞範繭 (憲夢淵蓋顧憲衊選網觸, 0.07 ~ 0.31) 更多 | 积极 | 2018-10-22 |
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