地舒单抗生物类似药 (Fresenius Kabi)(Denosumab-bnht) - 药物靶点：RANKL_在研适应症：骨质疏松性骨折，骨癌，骨病_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Denosumab Biosimilar (Fresenius Kabi Pharmaceuticals Holding LLC)、地舒单抗生物类似药（Fresenius Kabi Pharmaceuticals Holding LLC）、FKS518

+ [2]

靶点

RANKL

作用方式

抑制剂

作用机制

RANKL抑制剂(肿瘤坏死因子配体超家族成员11抑制剂)

治疗领域

肿瘤免疫系统疾病内分泌与代谢疾病+ [3]

在研适应症

骨质疏松性骨折骨癌骨病+ [8]

非在研适应症-

原研机构

Fresenius Kabi Pharmaceuticals Holding LLC

在研机构

Fresenius Kabi Deutschland GmbH

Fresenius Kabi USA LLC

非在研机构

Fresenius Kabi SwissBioSim GmbH

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2025-03-25),

骨病骨折骨巨细胞瘤+ [6]

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 94568L

当前序列信息引自: *****

Sequence Code 143522H

当前序列信息引自: *****

关联

2

项与地舒单抗生物类似药 (Fresenius Kabi) 相关的临床试验

EUCTR2021-003609-24-BG

/ Completed临床3期

A randomised, double-blind, parallel, multicentre, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 (proposed denosumab biosimilar) versus Prolia® (EU-sourced) in postmenopausal women with osteoporosis (SIMBA Study)

开始日期2022-02-15

申办/合作机构

mAbxience Research SL

NCT04934072

/ Completed临床3期

A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab With Prolia® in Postmenopausal Women With Osteoporosis (LUMIADE-3 Study)

The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).

开始日期2021-06-16

申办/合作机构

Fresenius Kabi SwissBioSim GmbH

100 项与地舒单抗生物类似药 (Fresenius Kabi) 相关的临床结果

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100 项与地舒单抗生物类似药 (Fresenius Kabi) 相关的转化医学

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100 项与地舒单抗生物类似药 (Fresenius Kabi) 相关的专利（医药）

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3

项与地舒单抗生物类似药 (Fresenius Kabi) 相关的文献（医药）

2025-11-04·Journal of the Endocrine Society

LUMIADE 3: Therapeutic Equivalence of Denosumab Biosimilar FKS518 to Reference Product in Postmenopausal Osteoporosis

Article

作者: Varone, Elsa ; Valter, Ivo ; Ferrari, Serge ; Supronik, Jerzy ; Krecipro-Nizinska, Ewa ; Petit-Frere, Corinne ; Pluskiewicz, Wojciech ; Szeles, Peter

Abstract:

Objectives:

To demonstrate therapeutic equivalence of the proposed denosumab biosimilar FKS518 to the originator denosumab (US-licensed Prolia®, reference product), a potent antiresorptive biologic that increases bone mineral density (BMD) and reduces the risk of fractures, in women with postmenopausal osteoporosis.

Methods:

This 78-week double-blind, controlled, randomized, multicenter, multiple-dose, 2-arm, parallel-group study compared the efficacy (BMD), pharmacodynamic (bone biomarkers), safety, tolerability, and immunogenicity profiles of FKS518 with those of reference denosumab in women with postmenopausal osteoporosis. Primary—percentage change from baseline to 52 weeks in lumbar spine BMD and area under the effect curve from baseline to week 26 of serum C-terminal cross-linking telopeptide of type 1 collagen—and secondary results from the 52-week core treatment period are reported here.

Results:

Postmenopausal women with osteoporosis were randomized to receive 60 mg of FKS518 (n = 277) or reference denosumab (n = 276) every 26 weeks. Demographics, baseline characteristics and medical history were similar between treatment groups. Therapeutic equivalence of FKS518 and reference denosumab was demonstrated for efficacy and pharmacodynamic characteristics. All sensitivity analyses, supportive estimands, secondary efficacy, and pharmacodynamic endpoint analyses consistently showed similarity between the 2 products. Safety outcomes were consistent with the known safety profile of denosumab and were comparable between FKS518 and reference denosumab. Immunogenicity was infrequently observed and similar between the FKS518 and the reference denosumab groups.

Conclusion:

This study demonstrated therapeutic equivalence of, and comparable pharmacokinetics, safety, and immunogenicity profiles between FKS518 and reference denosumab, completing the clinical evidence to propose FKS518 as a biosimilar to denosumab.

Bioanalysis

Refined ADA testing strategy to overcome sRANKL interference in denosumab/FKS518 immunogenicity assessment

Article

作者: Soares de Souza, Adriano L. ; Buccarello, Anna Lucia ; Ullmann, Martin ; Petit-Frere, Corinne

BACKGROUND:

Fresenius Kabi developed FKS518, a fully human monoclonal antibody biosimilar to denosumab, that inhibits osteoclast activation by targeting the receptor activator of nuclear factor kappa-Β ligand (RANKL). RANKL exists as a trimeric soluble protein (sRANKL) with high affinity for denosumab. Post-dose, sRANKL levels can rise due to drug-target complex accumulation, creating a risk of interference in bridging anti-drug antibodies (ADA) assays, particularly after acid dissociation.

METHODS:

We evaluated sRANKL interference in the ADA bridging assay and, to competitively block sRANKL, we introduced a specificity tier by adding osteoprotegerin (OPG). This approach enabled reanalysis of previously ADA-positive samples to confirm whether signals represented true ADA responses or artifacts caused by sRANKL interference.

RESULTS:

Acid dissociation significantly exacerbated target interference, resulting in ADA positivity rates of ~96-98% in clinical studies. Introducing a specificity tier corrected incidence to ≤3.9%. OPG incorporation did not change the minimum required dilution (MRD) of the assay and did not affect signals for negative/positive control, confirming assay integrity.

DISCUSSION:

These findings underscore the importance of early interference assessment and mitigation. A multi-tiered strategy, encompassing screening, confirmatory, and specificity tiers, provided a robust solution applicable to programs facing similar challenges.

Bioanalysis

Development and validation of a method for quantitation of CTx-1 for the assessment of biosimilarity of FKS518, a denosumab biosimilar

Article

作者: Buccarello, Anna Lucia ; Soares de Souza, Adriano L. ; Ullmann, Martin ; Berthet, Amandine ; Petit-Frere, Corinne

Fresenius Kabi has developed FKS518, a fully human monoclonal antibody biosimilar to denosumab. The clinical development program included two randomized comparative trials: a PK study in healthy volunteers and a safety and efficacy study in osteoporosis patients. The demonstration of similarity and equivalence between FKS518 and reference denosumab included the quantitation of the serum biomarker C-terminal cross-linking telopeptide of Type 1 collagen (CTx-1), a well-established marker of bone resorption. This paper details the development, validation, and analytical performance of the method for CTx-1 quantitation, emphasizing how the Context of Use (CoU) shaped the validation requirements. Application of the method in samples from the pharmacokinetic (PK) equivalence study allowed demonstration of pharmacodynamic (PD) similarity between FKS518 and Prolia. This publication also addresses the use of endogenous serum control (ESC) samples in monitoring assay performance. A retrospective analysis indicated that applying more flexible ranges and/or omitting ESC-based criteria for run acceptance would not have substantially changed the CTx-1 results. While recognizing the value of ESCs for stability and trending analysis and the importance of rigorous biomarker method development and validation in the assessment of biosimilarity, this paper fosters the discussion whether run acceptance based on tight ESC acceptance limits is always necessary.

12

项与地舒单抗生物类似药 (Fresenius Kabi) 相关的新闻（医药）

2025-12-01

·Fresenius

Fresenius Launches Denosumab Biosimilars in EU

Fresenius announced today the launch of its denosumab biosimilars, Conexxence® 1 (denosumab) and Bomyntra® 2 (denosumab), in Europe. These biosimilars received approval from the European Commission in July 2025 for all indications of the reference products Prolia® 3 (denosumab) and Xgeva® 4 (denosumab), respectively. “Being the first biosimilar company with a pre-filled syringe for the denosumab oncology indication in Europe, showcases our commitment to offering new treatment options that support patient care and affordability across Europe,” said Dr. Sang Jin Pak, President Biopharma. This milestone marks the next step in the company’s ambition to drive accessibility to high-quality biosimilar therapies, with multiple molecules in early and late-stage development. By continuing its successful track record in the biosimilars space, Fresenius further strengthens its (Bio)Pharma platform, a key pillar of the #FutureFresenius strategy. 1. Conexxence® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. 2. Bomyntra® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. 3. Prolia® is a registered trademarks of Amgen Inc. 4. Xgeva® is a registered trademarks of Amgen Inc.

上市批准生物类似药

2025-08-05

·Fresenius

Fresenius announces licensing agreement with Polpharma Biologics to commercialize a proposed vedolizumab biosimilar candidate

Fresenius Kabi, part of the global healthcare company Fresenius, has entered a licensing agreement with Polpharma Biologics S.A., a developer and manufacturer of biosimilar products, based in Poland. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics’ vedolizumab biosimilar candidate PB016 globally, except the Middle East and North Africa, pending approval by respective regulatory authorities. PB016 is a biosimilar candidate to Entyvio®*, an integrin receptor antagonist used in the treatment of moderately to severely active ulcerative colitis and Crohn’s disease. “Today marks a significant milestone in our journey to provide patients with access to affordable, high-quality biosimilar treatments,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “The in-licensing of PB016 from Polpharma Biologics underscores our commitment to expanding our autoimmune biosimilars portfolio and addressing the unmet needs of patients with chronic inflammatory diseases.” This agreement builds on Fresenius Kabi’s successful track record in the biosimilars market, including the recent FDA and EC approvals of its denosumab and ustekinumab biosimilars. This milestone underscores Fresenius Kabi’s commitment to broadening access to essential, high-quality biosimilar therapies. Through this agreement, Fresenius is strengthening its (Bio)Pharma platform, which is a key pillar of the #FutureFresenius strategy. *Entyvio® is a registered trademark of Takeda.

引进/卖出上市批准

2025-07-23

·Fresenius

Fresenius Receives European Commission Approval for Denosumab Biosimilars

July 23, 2025 – Fresenius announced today that the European Commission has granted approval for their denosumab biosimilars Conexxence®* and Bomyntra®* in Europe. The two approvals cover all indications of the reference products including osteoporosis in postmenopausal women and at-risk men, treatment-related bone loss, prevention of skeletal complications from cancer metastasis to bone, and giant cell tumor of bone. This milestone marks a significant advancement in Fresenius Kabi’s mission to expand access to high-quality biosimilar therapies. It also reinforces the business’ commitment to strengthening its Biopharma platform, a key pillar of the #FutureFresenius strategy. *Conexxence and *Bomyntra are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries.

上市批准

100 项与地舒单抗生物类似药 (Fresenius Kabi) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M05BX04	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
骨质疏松性骨折	欧盟	Fresenius Kabi Deutschland GmbH	2025-07-18
骨质疏松性骨折	冰岛	Fresenius Kabi Deutschland GmbH	2025-07-18
骨质疏松性骨折	列支敦士登	Fresenius Kabi Deutschland GmbH	2025-07-18
骨质疏松性骨折	挪威	Fresenius Kabi Deutschland GmbH	2025-07-18
骨癌	欧盟	Fresenius Kabi Deutschland GmbH	2025-07-17
骨癌	冰岛	Fresenius Kabi Deutschland GmbH	2025-07-17
骨癌	列支敦士登	Fresenius Kabi Deutschland GmbH	2025-07-17
骨癌	挪威	Fresenius Kabi Deutschland GmbH	2025-07-17
骨病	美国	Fresenius Kabi USA LLC	2025-03-25
骨折	美国	Fresenius Kabi USA LLC	2025-03-25
骨巨细胞瘤	美国	Fresenius Kabi USA LLC	2025-03-25
糖皮质激素诱导的骨质疏松症	美国	Fresenius Kabi USA LLC	2025-03-25
恶性肿瘤体液性高钙血症	美国	Fresenius Kabi USA LLC	2025-03-25
多发性骨髓瘤	美国	Fresenius Kabi USA LLC	2025-03-25
骨质疏松症	美国	Fresenius Kabi USA LLC	2025-03-25
绝经期后骨质疏松	美国	Fresenius Kabi USA LLC	2025-03-25
实体瘤	美国	Fresenius Kabi USA LLC	2025-03-25

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Literature 人工标引	N/A	-	213	FKS518	蓋憲糧艱積憲簾齋壓鑰(淵積憲製襯艱鑰壓壓糧) = 糧簾鬱築遞壓製製憲簾憲構觸鹹遞廠鏇餘憲鏇 (獵襯選鏇鏇襯憲壓艱齋 ) 更多	积极	2024-05-29
				Denosumab originator	蓋憲糧艱積憲簾齋壓鑰(淵積憲製襯艱鑰壓壓糧) = 夢鬱積製蓋窪夢獵範觸憲構觸鹹遞廠鏇餘憲鏇 (獵襯選鏇鏇襯憲壓艱齋 ) 更多