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Last update 28 Aug 2026
Adalimumab biosimilar(Alvotech)
Last update 28 Aug 2026
Overview
Basic Info
Drug Type Biosimilar, Monoclonal antibody |
Synonyms Adalimumab Biosimilar (Alvotech hf), 阿达木单抗生物类似药（Alvotech hf）, AVT-02 + [8] |
Target |
Action inhibitors |
Mechanism TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (12 Nov 2021), |
Regulation- |
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Structure/Sequence
Sequence Code 26792L
The sequence is quoted from: *****
Sequence Code 88699H
The sequence is quoted from: *****
Related
10
Clinical Trials associated with Adalimumab biosimilar(Alvotech)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 Clinical Results associated with Adalimumab biosimilar(Alvotech)
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100 Translational Medicine associated with Adalimumab biosimilar(Alvotech)
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100 Patents (Medical) associated with Adalimumab biosimilar(Alvotech)
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10
Literatures (Medical) associated with Adalimumab biosimilar(Alvotech)01 Jun 2026Rheumatology 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
Author: Vender, Ronald B ; Narula, Neeraj ; Afif, Waqqas ; Thorne, Carter ; Lynde, Charles W ; Steinhart, A Hillary ; 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.
01 Jan 2024Immunotherapy 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
Author: Reznichenko, Nataliya ; Guenzi, Eric ; 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.
01 Jan 2024Therapeutic advances in chronic disease
The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira
Review
Author: 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.
162
News (Medical) associated with Adalimumab biosimilar(Alvotech)27 Aug 2026
27 Aug 2026
27 Aug 2026
100 Deals associated with Adalimumab biosimilar(Alvotech)
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Adalimumab biosimilar(Alvotech) |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Polyarticular Juvenile Idiopathic Arthritis | Canada | 10 Jan 2022 | |
| Crohn's disease, active moderate | European Union | 15 Nov 2021 | |
| Crohn's disease, active moderate | Iceland | 15 Nov 2021 | |
| Crohn's disease, active moderate | Liechtenstein | 15 Nov 2021 | |
| Crohn's disease, active moderate | Norway | 15 Nov 2021 | |
| Crohn's disease, active severe | European Union | 15 Nov 2021 | |
| Crohn's disease, active severe | Iceland | 15 Nov 2021 | |
| Crohn's disease, active severe | Liechtenstein | 15 Nov 2021 | |
| Crohn's disease, active severe | Norway | 15 Nov 2021 | |
| Panuveitis | European Union | 15 Nov 2021 | |
| Panuveitis | Iceland | 15 Nov 2021 | |
| Panuveitis | Liechtenstein | 15 Nov 2021 | |
| Panuveitis | Norway | 15 Nov 2021 | |
| Uveitis, Intermediate | European Union | 15 Nov 2021 | |
| Uveitis, Intermediate | Iceland | 15 Nov 2021 | |
| Uveitis, Intermediate | Liechtenstein | 15 Nov 2021 | |
| Uveitis, Intermediate | Norway | 15 Nov 2021 | |
| Uveitis, Posterior | European Union | 15 Nov 2021 | |
| Uveitis, Posterior | Iceland | 15 Nov 2021 | |
| Uveitis, Posterior | Liechtenstein | 15 Nov 2021 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Autoinflammatory disease | NDA/BLA | United States | 28 Feb 2022 | |
| Chronic large plaque psoriasis | Phase 3 | United States | 20 Feb 2019 | |
| Chronic large plaque psoriasis | Phase 3 | Estonia | 20 Feb 2019 | |
| Chronic large plaque psoriasis | Phase 3 | Poland | 20 Feb 2019 | |
| Chronic large plaque psoriasis | Phase 3 | Ukraine | 20 Feb 2019 | |
| Inflammation | Phase 1 | Australia | 20 Mar 2019 | |
| Inflammation | Phase 1 | New Zealand | 20 Mar 2019 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 4 | 324 | irxjoeicbq(zxsjnbeegh) = xzjtncgkgf ennjoudxqx (pniucoxdtt ) View more | Positive | 11 Jun 2026 | |||
Phase 4 | 324 | zazhivqrab(bjrgkenabg) = nioqwbhfws bcyzxxkuza (xagacgbmah ) View more | Positive | 10 Apr 2026 | |||
Phase 4 | 287 | lylrfoxqgx(tcvslwzcyp) = cgwfcejzro deoragjgfd (tvjkcafffa ) View more | Positive | 07 Mar 2025 | |||
Phase 3 | 107 | AVT02 with autoinjector (AI) | sngngnellj(jxfcckxsvc) = fvuxqehbga poxhptznit (jdoaugnkbe ) View more | - | 01 Jun 2022 | ||
AVT02 with pre-filled syringe (ALVOPAD-PEN) | sngngnellj(jxfcckxsvc) = dnazfrlaqx poxhptznit (jdoaugnkbe ) View more | ||||||
Phase 3 | 413 | pachstgmcf(eqzvejeecn) = gvrhbfxvkk dixmilojci (xumrkazeaj ) View more | Similar | 01 Nov 2021 | |||
pachstgmcf(eqzvejeecn) = djslesjmor dixmilojci (xumrkazeaj ) View more | |||||||
Not Applicable | 2,798 | oxlnrcybnt(qaxfknxuek) = cnitvddtbv smborzrnxo (ooutvjckku, 0.07 - 0.31) View more | Positive | 22 Oct 2018 |
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