Delving into the Latest Updates on Adalimumab biosimilar(Alvotech) with Synapse

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

TNF-α

Action

inhibitors

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [3]

Active Indication

Polyarticular Juvenile Idiopathic ArthritisCrohn's disease, active moderateCrohn's disease, active severe+ [20]

Inactive Indication

Autoinflammatory diseaseChronic large plaque psoriasis

Originator Organization

Alvotech hf

Active Organization

STADA Arzneimittel AG

Cipla Ltd.Cipla Australia Pty Ltd.

+ [5]

Inactive Organization

Alvotech Swiss AGAlvotech Holdings SA

License Organization

Teva Pharmaceutical Industries Ltd.

Alvotech hfCipla BioTec Ltd.

+ [7]

Drug Highest PhaseApproved

First Approval Date

European Union (12 Nov 2021),

Ankylosing SpondylitisArthritis, PsoriaticAxial Spondyloarthritis+ [14]

Regulation-

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Structure/Sequence

Sequence Code 26792L

The sequence is quoted from: *****

Sequence Code 88699H

The sequence is quoted from: *****

The purpose of the Phase IV study is to investigate the effects of both Volume and Citrate on Injection Site Pain (ISP), adherence, patient satisfaction, Quality of Life, and Disease Assessment in the Canadian Adalimumab Market.
The phase IV study is an observational, pan-Canadian, multidisciplinary study aiming to enroll 600 patients across 50-70 sites across 3 different Therapeutic Areas (GI, Rheum, Derm).

Start Date09 Jan 2023

Sponsor / Collaborator

JAMP Pharma Corp.

NCT04453137

/ CompletedPhase 3

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

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

Start Date30 Jun 2020

Sponsor / Collaborator

Alvotech Swiss AG

NCT04224194

/ CompletedPhase 3

Assessment of Real-life Patient Handling Experience of AVT02 Administered Subcutaneous With an Auto-Injector in Patients With Moderate to Severe Active RA

To assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who self-inject AVT02 subcutaneously (SC).

Start Date04 Nov 2019

Sponsor / Collaborator

Alvotech Swiss AG

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 2026·Rheumatology 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 ; 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.

01 Jan 2024·Immunotherapy 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 2024·Therapeutic 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.

157

News (Medical) associated with Adalimumab biosimilar(Alvotech)

10 Aug 2026

·www.biospace.com

Alvotech to Report Financial Results for H1 2026

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: ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); 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.

Financial StatementBiosimilar

29 Jul 2026

·www.globenewswire.com

Alvotech announces successful closure of FDA inspection of manufacturing facility

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.

BiosimilarDrug Approval

29 Jul 2026

·www.globenewswire.com

Alvotech announces successful closure of FDA inspection of manufacturing facility

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.

BiosimilarDrug Approval

100 Deals associated with Adalimumab biosimilar(Alvotech)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Adalimumab biosimilar(Alvotech)	L04AB04	DB00051

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Polyarticular Juvenile Idiopathic Arthritis	Canada	JAMP Pharma Corp.	10 Jan 2022
Crohn's disease, active moderate	European Union	STADA Arzneimittel AG	15 Nov 2021
Crohn's disease, active moderate	Iceland	STADA Arzneimittel AG	15 Nov 2021
Crohn's disease, active moderate	Liechtenstein	STADA Arzneimittel AG	15 Nov 2021
Crohn's disease, active moderate	Norway	STADA Arzneimittel AG	15 Nov 2021
Crohn's disease, active severe	European Union	STADA Arzneimittel AG	15 Nov 2021
Crohn's disease, active severe	Iceland	STADA Arzneimittel AG	15 Nov 2021
Crohn's disease, active severe	Liechtenstein	STADA Arzneimittel AG	15 Nov 2021
Crohn's disease, active severe	Norway	STADA Arzneimittel AG	15 Nov 2021
Panuveitis	European Union	STADA Arzneimittel AG	15 Nov 2021
Panuveitis	Iceland	STADA Arzneimittel AG	15 Nov 2021
Panuveitis	Liechtenstein	STADA Arzneimittel AG	15 Nov 2021
Panuveitis	Norway	STADA Arzneimittel AG	15 Nov 2021
Uveitis, Intermediate	European Union	STADA Arzneimittel AG	15 Nov 2021
Uveitis, Intermediate	Iceland	STADA Arzneimittel AG	15 Nov 2021
Uveitis, Intermediate	Liechtenstein	STADA Arzneimittel AG	15 Nov 2021
Uveitis, Intermediate	Norway	STADA Arzneimittel AG	15 Nov 2021
Uveitis, Posterior	European Union	STADA Arzneimittel AG	15 Nov 2021
Uveitis, Posterior	Iceland	STADA Arzneimittel AG	15 Nov 2021
Uveitis, Posterior	Liechtenstein	STADA Arzneimittel AG	15 Nov 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autoinflammatory disease	NDA/BLA	United States	Alvotech Holdings SA	28 Feb 2022
Chronic large plaque psoriasis	Phase 3	United States	Alvotech Swiss AG	20 Feb 2019
Chronic large plaque psoriasis	Phase 3	Estonia	Alvotech Swiss AG	20 Feb 2019
Chronic large plaque psoriasis	Phase 3	Poland	Alvotech Swiss AG	20 Feb 2019
Chronic large plaque psoriasis	Phase 3	Ukraine	Alvotech Swiss AG	20 Feb 2019
Inflammation	Phase 1	Australia	Alvotech Swiss AG	20 Mar 2019
Inflammation	Phase 1	New Zealand	Alvotech Swiss AG	20 Mar 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASE PAIN (EULAR2026)	Phase 4	Psoriasis \| Arthritis, Psoriatic \| Rheumatoid Arthritis ... View more	324	AVT02	xoeujfcqkp(jdbgmcmbnm) = ecaisufdxr ofraeaqcxe (ybfrstfmoi ) View more	Positive	11 Jun 2026
NCT05913817 (EASE PAIN, Pubmed \| Rheumatol Ther)	Phase 4	Collagen Diseases \| Skin Diseases	324	AVT02 (Simlandi)	ehxwkasbih(cnsyzfefac) = aolzqcwhxr dsyfohgfbp (asjbqrfvct ) View more	Positive	10 Apr 2026
EASE PAIN (AAD2025)	Phase 4	Multiple Hamartoma Syndrome \| Rheumatoid Arthritis \| Psoriasis of scalp	287	AVT02	whthuatzrt(xempjiomfd) = eeihhtbklr ebwuzhyevr (xjpyqbwezt ) View more	Positive	07 Mar 2025
NCT04224194 (EULAR2022)	Phase 3	Rheumatoid Arthritis	107	AVT02 with autoinjector (AI)	idsoyecnvy(coteugaeky) = exgjwcozrz flafkizjob (equfabahtv ) View more	-	01 Jun 2022
NCT04224194 (EULAR2022)	Phase 3	Rheumatoid Arthritis	107	AVT02 with pre-filled syringe (ALVOPAD-PEN)	idsoyecnvy(coteugaeky) = nlvcsonvwe flafkizjob (equfabahtv ) View more	-	01 Jun 2022
NCT03849404 (Pubmed \| BioDrugs) Manual	Phase 3	Chronic large plaque psoriasis	413	AVT02	buaoikgvdv(ihkiutbrak) = hgvtpdozxw uchylvrciv (rnjrjebeqv ) View more	Similar	01 Nov 2021
NCT03849404 (Pubmed \| BioDrugs) Manual	Phase 3	Chronic large plaque psoriasis	413	originator adalimumab	buaoikgvdv(ihkiutbrak) = eihbrgpnkr uchylvrciv (rnjrjebeqv ) View more	Similar	01 Nov 2021
Corrona RA registry (ACR2018)	Not Applicable	Rheumatoid Arthritis	2,798	Adalimumab	wvegtchacq(bwahwzrjcp) = wxximfscav qnwptirutl (cxdzcoivpz, 0.07 - 0.31) View more	Positive	22 Oct 2018

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Adalimumab biosimilar(Alvotech)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation