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

Overview

Basic Info

Drug Type

Fc fusion protein, Biosimilar

Synonyms

Aflibercept Biosimilar (Alvotech hf), 阿柏西普生物类似药（Alvotech hf）, AVT-06

+ [5]

Target

PGF x VEGF-A

Action

inhibitors

Mechanism

PGF inhibitors(Placental Growth Factor inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

Cardiovascular DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication

Inactive Indication-

Originator Organization

Alvotech hf

Active Organization

Advanz Pharma Ltd.

Alvotech hf

STADA Arzneimittel AG

+ [3]

Inactive Organization-

License Organization

Fuji Pharma Co., Ltd.

Alvotech hf

Polifarma SpA

+ [7]

Drug Highest PhaseApproved

First Approval Date

European Union (18 Aug 2025),

Diabetic macular oedemaMyopic choroidal neovascularizationRetinal vein occlusion-related macular edema+ [1]

Regulation-

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Structure/Sequence

Sequence Code 4715606

The sequence is quoted from: *****

In this randomized, double-masked, multicenter, active-controlled trial, treatment naïve participants received intravitreal injections of AVT06 or RP (2 mg) over 48 weeks. The primary endpoint was the change from baseline to Week 8 in best-corrected visual acuity (BCVA). Secondary endpoints included BCVA improvements and changes in Central Subfield Thickness (CST). PK, immunogenicity, and safety were also assessed.

RESULTS:

The 90% and 95% confidence intervals (-0.60, 2.14 and -0.86, 2.40, respectively) in least squares mean difference in BCVA letter score from baseline to Week 8 were contained within the pre-specified equivalence margin of ETDRS BCVA letter score of [-3.5 to 3.5], supporting the demonstration of comparative efficacy. Secondary efficacy outcomes were also comparable. PK analyses supported systemic safety. There were no clinically meaningful differences in immunogenicity profiles. Safety profiles were similar; most treatment-emergent adverse events were mild and unrelated to the study drug.

CONCLUSIONS:

Results supported a demonstration of comparable efficacy between AVT06 and RP aflibercept. Similar PK, immunogenicity, and safety profiles were also shown.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov identifier is NCT05155293; ClinicalTrialsRegister.eu identifier is 2021-003651-42.

Frontiers in Pharmacology

Efficacy and safety of aflibercept biosimilars compared to aflibercept in the treatment of neovascular age-related macular degeneration: a systematic review and meta-analysis

Review

Author: Zhou, Yating ; Wang, Zixun ; Zhan, Zongyue ; Liu, Chen

Background:

This study aimed to evaluate the aflibercept biosimilars compared to the reference product aflibercept (Eylea®) in terms of efficacy, safety, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD).

Methods:

We searched PubMed, Web of Science, Cochrane Library, and Embase from inception to 13 August 2025. We included studies reporting changes in best-corrected visual acuity (BCVA), changes in central subfield thickness (CST), changes in the leakage lesion of choroidal neovascularization (CNV), and adverse events from baseline to endpoint. All statistical analyses were performed using Stata 18.0 software and assessed the certainty of evidence for each outcome using the GRADE approach.

Results:

A total of seven studies involving 2,829 participants were included. There were no statistically significant differences in visual and anatomical outcomes between the aflibercept biosimilars (SB15, P041, SDZ-AFL, AVT06, SCD411, ABP 938, and QL1207) and the reference aflibercept. No significant differences were detected between aflibercept biosimilars and the reference aflibercept with respect to serious ocular and non-ocular adverse events [relative risk (RR) = 1.71, 95% confidence interval (CI): 0.70, 4.19; I2 = 0.0%, P = 0.913; RR = 1.08, 95% CI: 0.82, 1.42; I2 = 0.0%, P = 0.936, respectively). Although a slightly higher rate of treatment-emergent adverse events (TEAEs) was noted in the biosimilar group (RR = 1.07, 95% CI: 1.00–1.15; I 2 = 26.1%), the difference was not statistically significant ( P = 0.248).

Conclusion:

Based on the seven included randomized controlled clinical trials, aflibercept biosimilars demonstrated comparable safety and efficacy to the reference aflibercept. Future research requires more rigorous studies.

58

News (Medical) associated with Aflibercept 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 Aflibercept biosimilar (Alvotech)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Age Related Macular Degeneration	Japan	Fuji Pharma Co., Ltd.	19 Sep 2025
Diabetic macular oedema	European Union	Advanz Pharma Ltd.	18 Aug 2025
Diabetic macular oedema	European Union	STADA Arzneimittel AG	18 Aug 2025
Diabetic macular oedema	Iceland	Advanz Pharma Ltd.	18 Aug 2025
Diabetic macular oedema	Iceland	STADA Arzneimittel AG	18 Aug 2025
Diabetic macular oedema	Liechtenstein	Advanz Pharma Ltd.	18 Aug 2025
Diabetic macular oedema	Liechtenstein	STADA Arzneimittel AG	18 Aug 2025
Diabetic macular oedema	Norway	STADA Arzneimittel AG	18 Aug 2025
Diabetic macular oedema	Norway	Advanz Pharma Ltd.	18 Aug 2025
Myopic choroidal neovascularization	European Union	STADA Arzneimittel AG	18 Aug 2025
Myopic choroidal neovascularization	European Union	Advanz Pharma Ltd.	18 Aug 2025
Myopic choroidal neovascularization	Iceland	Advanz Pharma Ltd.	18 Aug 2025
Myopic choroidal neovascularization	Iceland	STADA Arzneimittel AG	18 Aug 2025
Myopic choroidal neovascularization	Liechtenstein	STADA Arzneimittel AG	18 Aug 2025
Myopic choroidal neovascularization	Liechtenstein	Advanz Pharma Ltd.	18 Aug 2025
Myopic choroidal neovascularization	Norway	STADA Arzneimittel AG	18 Aug 2025
Myopic choroidal neovascularization	Norway	Advanz Pharma Ltd.	18 Aug 2025
Retinal vein occlusion-related macular edema	European Union	Advanz Pharma Ltd.	18 Aug 2025
Retinal vein occlusion-related macular edema	European Union	STADA Arzneimittel AG	18 Aug 2025
Retinal vein occlusion-related macular edema	Iceland	Advanz Pharma Ltd.	18 Aug 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Retinal Vascular Disorder	Phase 3	United States	Alvotech Swiss AG	11 Mar 2024
Retinal Vascular Disorder	Phase 3	Latvia	Alvotech Swiss AG	11 Mar 2024
Retinal Vein Occlusion	Phase 3	United States	Alvotech Swiss AG	11 Mar 2024
Retinal Vein Occlusion	Phase 3	Latvia	Alvotech Swiss AG	11 Mar 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05155293 ( AVT06-GL-C01 \| ALVOEYE, GlobeNewswire) Manual	Phase 3	Wet age-related macular degeneration	-	AVT06	lbknpqlxvt(ekcyjfjqey) = results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea jpvficyulb (yonycpoxak ) Met	Similar	03 Jan 2024
				Eylea

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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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Aflibercept 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