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

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Denosumab Biosimilar (Alvotech hf), 地舒单抗生物类似药（Alvotech hf）, AVT 03 (Alvotech)

+ [7]

Target

RANKL

Action

inhibitors

Mechanism

RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [4]

Active Indication

Bone CancerBone Diseases, MetabolicOsteoporosis+ [11]

Inactive Indication-

Originator Organization

Alvotech hf

Active Organization

Reddy Holding GmbHAlvotechAlvotech Swiss AG

+ [4]

Inactive Organization-

License Organization

Fuji Pharma Co., Ltd.

Alvotech hf

STADA Arzneimittel AG

+ [5]

Drug Highest PhaseApproved

First Approval Date

Japan (19 Sep 2025),

Multiple MyelomaNeoplasm MetastasisSolid tumor

Regulation-

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Structure/Sequence

Sequence Code 94568L

The sequence is quoted from: *****

Sequence Code 143522H

The sequence is quoted from: *****

Participants received AVT03 or RP; 60 mg subcutaneous on Day 1 and Month 6. At Month 12, AVT03 group received 3^rd dose while RP group received either a 3^rd dose of RP or a dose of AVT03. Primary endpoints were percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months and area under the effect curve (AUEC)_0-6 months of percent change from baseline (%Cfb) in serum C-terminal telopeptide of type I collagen (sCTX-1). Safety and immunogenicity were evaluated.

RESULTS:

The 95% confidence interval (CI)s of the least squares means difference between treatments for percent change from baseline in lumbar spine BMD to Month 12 (-0.58, 0.82) were entirely contained within the prespecified margin (-1.45%, 1.45%), supporting demonstration of comparative efficacy. The 95% CIs of the geometric mean ratio between treatments for AUEC_0-6 months of %Cfb sCTX-1 (0.97, 1.03) were entirely contained within the prespecified margin (0.80, 1.25), supporting demonstration of pharmacodynamic similarity. Safety and immunogenicity profiles were comparable throughout.

CONCLUSION:

Data supported demonstration of comparative efficacy between AVT03 and RP denosumab. Safety and immunogenicity profiles were similar.

TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT05395091.

03 Jun 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, pharmacodynamic, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (60 mg/mL) in healthy male adults

Article

Author: Lukasz Jaskiewicz ; Masna Rai ; Steffen Leutz ; Ruth Ruffieux ; Fausto Berti ; Hendrik Otto ; Felicitas Bullo ; Serena Stamatakos ; Anel Pretorius ; Abid Sattar

BACKGROUND:

This study compared pharmacokinetic (PK) similarity, pharmacodynamic, safety, and immunogenicity of AVT03, a candidate biosimilar, with reference product (RP) denosumab (Prolia).

METHODS:

Healthy male participants (N = 209) were randomized 1:1 to receive one 60 mg dose of either AVT03 or RP. PK similarity was demonstrated if the 90% confidence intervals (CI) for the ratio of geometric means for the primary PK parameters (C_max and AUC_0-inf for EMA; C_max and AUC_0-t for FDA and PMDA) were within the prespecified margins of 80.00% and 125.00%. Secondary PK parameters assessed were AUC_0-24, T_max, K_el, t_1/2, V_z/F, and CL/F. The serum biomarker of bone resorption, CTX-1 was evaluated to compare pharmacodynamic (PD) profiles. Safety and immunogenicity were also assessed.

RESULTS:

The 90% CI for the ratio of geometric means for primary PK parameters was contained between the pre-specified margins of 80.00% and 125.00% (C_max [102.23, 113.64]; AUC_0-inf [107.17, 118.87]; AUC_0-t [107.72, 120.42]), supporting demonstration of PK similarity between AVT03 and RP. Secondary PK parameters supported the analysis. PD, safety and immunogenicity profiles were comparable between the two arms.

CONCLUSION:

Results supported a demonstration of PK similarity between AVT03 and RP denosumab. Comparable PD, safety and immunogenicity profiles were also shown.

CLINICAL TRIAL REGISTRATION:

The clinical trial is registered at https://www.clinicaltrials.gov under identifier NCT05126784.

03 Jun 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (70 mg/mL) in healthy male adults

Article

Author: Rai, Masna ; Otto, Hendrik ; Stamatakos, Serena ; Berti, Fausto ; Jaskiewicz, Lukasz ; Bullo, Felicitas ; Leutz, Steffen ; Tomaszewska-Kiecana, Monika ; Sattar, Abid

BACKGROUND:

This study (NCT05876949) compared the pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT03, a candidate biosimilar, with reference product (RP) denosumab (Xgeva).

METHODS:

Healthy male participants (N = 208, including 24 Japanese participants) were randomized 1:1 to receive one 120 mg dose of AVT03, or RP. PK similarity was demonstrated if the 90% confidence intervals (CI) for the ratio of geometric means for the primary PK parameters C_max and AUC_0-t were within 80.00% and 125.00%. Additional PK parameters included AUC_0-inf, t_max, K_el, t_1/2, V_z/F, and CL/F. Safety and immunogenicity were also assessed.

RESULTS:

The 90% CIs for the ratio of geometric means for the primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (C_max [98.26, 110.00]; AUC_0-t [102.30, 113.60]), supporting demonstration of PK similarity. Consistency between Japanese participants and the overall population was shown. Safety and immunogenicity profiles were comparable between the two treatment arms.

CONCLUSION:

Results supported demonstration of PK similarity between AVT03 and RP. AVT03 had a safety and immunogenicity profile comparable to RP.

CLINICAL TRIAL REGISTRATION:

The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05876949); and 2022 -003,659-32 (EudraCT).

55

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

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bone Cancer	European Union	Alvotech	25 Nov 2025
Bone Cancer	Iceland	Alvotech	25 Nov 2025
Bone Cancer	Liechtenstein	Alvotech	25 Nov 2025
Bone Cancer	Norway	Alvotech	25 Nov 2025
Bone Diseases, Metabolic	European Union	Alvotech	25 Nov 2025
Bone Diseases, Metabolic	Iceland	Alvotech	25 Nov 2025
Bone Diseases, Metabolic	Liechtenstein	Alvotech	25 Nov 2025
Bone Diseases, Metabolic	Norway	Alvotech	25 Nov 2025
Osteoporosis	European Union	Alvotech	25 Nov 2025
Osteoporosis	Iceland	Alvotech	25 Nov 2025
Osteoporosis	Liechtenstein	Alvotech	25 Nov 2025
Osteoporosis	Norway	Alvotech	25 Nov 2025
Fractures, Spontaneous	European Union	STADA Arzneimittel AG	17 Nov 2025
Fractures, Spontaneous	European Union	Reddy Holding GmbH	17 Nov 2025
Fractures, Spontaneous	Iceland	STADA Arzneimittel AG	17 Nov 2025
Fractures, Spontaneous	Iceland	Reddy Holding GmbH	17 Nov 2025
Fractures, Spontaneous	Liechtenstein	STADA Arzneimittel AG	17 Nov 2025
Fractures, Spontaneous	Liechtenstein	Reddy Holding GmbH	17 Nov 2025
Fractures, Spontaneous	Norway	Reddy Holding GmbH	17 Nov 2025
Fractures, Spontaneous	Norway	STADA Arzneimittel AG	17 Nov 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporotic Fractures	NDA/BLA	European Union	STADA Arzneimittel AG	18 Sep 2025
Osteoporotic Fractures	NDA/BLA	European Union	Reddy Holding GmbH	18 Sep 2025
Immune System Diseases	Preclinical	Iceland	Alvotech hf	-
Neoplasms	Preclinical	Iceland	Alvotech hf	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05876949 (AVT03-GL-P03, CTgov)	Phase 1	-	208	AVT03 (Experimental Arm AVT03 120mg)	euppsakhzu(kppjopicdx) = fmzqwhbikk nxwjjbzgtg (rjlyytlecs, 34) View more	-	15 May 2025
				Denosumab (Active Comparator Xgeva 120mg)	euppsakhzu(kppjopicdx) = gebtflubyl nxwjjbzgtg (rjlyytlecs, 32) View more
NCT05395091 (WCO_IOF_ESCEO2025)	Phase 3	Osteoporosis, Postmenopausal	532	AVT03	hioptbdnws(lfxcvciidv): Geometric mean ratio = 1.0 (95.0% CI, 0.97 - 1.03)	Positive	10 Apr 2025
				Reference Product (RP) DENOSUMAB
NCT05876949 (WCO_IOF_ESCEO2025)	Phase 1	-	208	AVT03	ltuwinpxqd(pfyutecfzv) = gibhwxiugg mxjthuhxxq (gepucrssxt )	Positive	10 Apr 2025
				Reference Product	ltuwinpxqd(pfyutecfzv) = axkuraxdyq mxjthuhxxq (gepucrssxt )
NCT05126784 (WCO_IOF_ESCEO2025)	Phase 1	-	206	AVT03 (60 mg/mL)	-	Positive	10 Apr 2025
				Reference Product (60 mg/mL)
NCT05876949 (AVT03-GL-P03, GlobeNewswire) Manual	Phase 1	Osteoporosis, Postmenopausal	208	AVT03	enxrnhrcys(zzabfhntyc) = we have now obtained positive topline results from two PK studies, that show equivalent PK, safety, and tolerability of AVT03 compared to Prolia and Xgeva, respectively. wuacyvdcyo (fidhhsutsm ) Met	Similar	02 Jul 2024
				Prolia
NCT05126784 (AVT03-GL-P01, GlobeNewswire) Manual	Phase 1	-	-	AVT03	zxaxoactgg(mghtjzgkcj) = met its primary endpoints prsddleyze (aftymvgupx ) Met View more	Positive	29 Jan 2024

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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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Denosumab 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