Delving into the Latest Updates on Bevacizumab biosimilar(Fujifilm Kyowa Kirin Biologics Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Bevacizumab biosimilar, Equidacent, FKB-238

Target

VEGF-A

Action

inhibitors

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors), Angiogenesis inhibitors

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [3]

Active Indication-

Inactive Indication

Colonic CancerFallopian Tube CarcinomaMetastatic breast cancer+ [11]

Originator Organization

Fujifilm Kyowa Kirin Biologics Co., Ltd.

Active Organization-

Inactive Organization

Centus Biotherapeutics Europe Ltd.

Centus Biotherapeutics Ltd.

License Organization

AstraZeneca PLCFujifilm Kyowa Kirin Biologics Co., Ltd.

Drug Highest PhaseWithdrawn

First Approval Date

European Union (24 Sep 2020),

Colonic CancerFallopian Tube CarcinomaMetastatic breast cancer+ [9]

Regulation-

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Structure/Sequence

Sequence Code 41632H

The sequence is quoted from: *****

Sequence Code 41637L

The sequence is quoted from: *****

In a randomized, double-blind, parallel-group study, 99 healthy men received 5 mg of FKB238, EU-bevacizumab, or US-bevacizumab in a 1 : 1 : 1 ratio by intravenous infusion. PK, immunogenicity, adverse events, local tolerability, vital signs, electrocardiogram, and safety tests of blood and urine were assessed before and up to 99 days after treatment.

RESULTS:

The 90% confidence interval for the ratios of the primary (area under the curve ((AUC)_0-t and AUC_0-inf) and secondary (maximum concentration (C_max) and elimination half-life (T_1/2)) geometric mean PK parameters were entirely within the acceptance range for bioequivalence of 0.80 - 1.25 for all 3 pairwise comparisons by analysis of covariance, with baseline characteristics of age and body weight as covariates. FKB238 was well tolerated in healthy participants, and anti-drug antibody (ADA) incidence was low and similar in all treatment groups.

CONCLUSION:

The study demonstrated the PK similarity of FKB238 to both EU-bevacizumab and US-bevacizumab after a single intravenous infusion. FKB238 was well tolerated in healthy participants, and there was no difference in ADA incidence among the 3 products.

01 Sep 2021·Clinical Drug Investigation

FKB238: A Bevacizumab Biosimilar

Review

Author: Syed, Yahiya Y

FKB238 is a biosimilar of bevacizumab (a monoclonal antibody against vascular endothelial growth factor) approved for use in the same types of cancer as reference bevacizumab. FKB238 has similar physicochemical and pharmacodynamic properties to those of reference bevacizumab and pharmacokinetic similarity was shown in healthy volunteers and in patients with non-small cell lung cancer (NSCLC). FKB238 demonstrated equivalent clinical efficacy to reference bevacizumab in patients with advanced or recurrent nonsquamous NSCLC, with similar tolerability, safety and immunogenicity profiles.

01 Jul 2021·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapyQ3 · MEDICINE

Efficacy and Safety of Bevacizumab Biosimilar FKB238 Versus Originator Bevacizumab: Results from AVANA, a Phase III Trial in Patients with Non-Squamous Non-Small-Cell Lung Cancer (non-sq-NSCLC)

Q3 · MEDICINE

Article

Author: Fu, Dongyue ; Dvorkin, Mikhail ; Bashir, Zahid ; Andric, Zoran ; Kuchava, Vladimer ; Zhavrid, Edvard ; Galiulin, Rinat ; Abert, Istvan ; Syrigos, Konstantinos ; Trukhin, Dmytro ; Galic, Kristina ; Bondarenko, Igor N ; Jones, Stephanie ; Kassalow, Laurent M ; Sriuranpong, Virote

BACKGROUND:

Bevacizumab is an antiangiogenic recombinant humanized monoclonal antibody that inhibits tumor growth. FKB238, a bevacizumab biosimilar, has analytical pharmacokinetic and safety profiles similar to those of bevacizumab.

OBJECTIVE:

This phase III trial (NCT02810457) compared the efficacy and safety of FKB238 with that of bevacizumab in patients with advanced/recurrent non-squamous non-small-cell lung cancer (non-sq-NSCLC).

METHODS:

This global, multicenter, double-blind, parallel, randomized, comparative clinical trial enrolled and randomized patients with advanced/recurrent non-sq-NSCLC to receive intravenous infusions of either FKB238 15 mg/kg or bevacizumab 15 mg/kg. All patients received intravenous infusions of paclitaxel 200 mg/m² and carboplatin (area under the curve 6.0) immediately prior to investigational products for 4-6 cycles. FKB238 and bevacizumab were administered on day 1 of each 21-day cycle until objective progressive disease by RECIST version 1.1 or other discontinuation criteria were met. The primary efficacy endpoint was overall response rate (ORR), including complete and partial response and based on blinded independent central review assessment. Other efficacy determinations included progression-free survival (PFS), overall survival (OS), and immunogenicity. Adverse events and severity were reported.

RESULTS:

The ORR for the intent-to-treat (ITT) population (N = 731) was 51.6% in the FKB238 arm (N = 364) and 53.7% in the bevacizumab arm (N = 367). The FKB238:bevacizumab ORR ratio (ITT population) was 0.96 (90% confidence interval [CI] 0.86-1.08), and the difference in ORR (per-protocol set) between FKB238 and bevacizumab was - 0.02 (95% CI - 0.09 to 0.06). Both CIs fell within the prespecified equivalence margins. Estimated median PFS was 7.72 and 7.62 months in the FKB238 and bevacizumab arms, respectively (hazard ratio 0.97; 95% CI 0.82-1.16). Treatment-emergent adverse events (TEAEs) were reported for 94.2% and 95.1% of patients in the FKB238 and bevacizumab arms, respectively. Grade 3 or higher TEAEs were reported for 53.6% and 55.5% of patients in the FKB238 and bevacizumab arms, respectively. Serious TEAEs were reported for 25.1% and 26.0% of patients treated with FKB238 and bevacizumab, respectively.

CONCLUSIONS:

Efficacy equivalence was demonstrated between the two drugs, and safety profiles were similar. There were no meaningful differences in efficacy and safety between FKB238 or bevacizumab in patients with non-sq-NSCLC.

TRIAL REGISTRATION NUMBER:

NCT02810457.

1

News (Medical) associated with Bevacizumab biosimilar(Fujifilm Kyowa Kirin Biologics Co., Ltd.)

14 Apr 2021

·www.globenewswire.com

New York, April 14, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Biosimilar Monoclonal Antibodies Forecast 2020-2030" - • Along with revenue prediction for the overall world market for biosimilar monoclonal antibodies, our investigation shows forecasts to 2027 for the market segmented by compound: • Infliximab • Rituximab • Abciximab • Trastuzumab • Adalimumab • Bevacizumab • This report also shows revenue to 2027 for individual biosimilar mAb products in the market: • Remsima/Inflectra • Infimab • Reditux • BI695500 • CT-P10 • BI695501 • FKB327 • FKB238 • Mabtas • AcellBia • Maball • Clotinab • Abcixirel • BCD-022 • BCD-021 • Herzuma • CANMAB/Hertraz • Our analyses show individual revenue forecasts to 2027 for these regional and national markets: • The US Biosimilar mAb Market • Japanese Biosimilar mAb Market • EU5 Biosimilar mAb Markets • BRIC and South Korea Biosimilar mAb Markets • Rest of the World Biosimilar mAb Market • This report profiles 10 leading companies either with biosimilar mAbs already on the market or in the pipeline • Our study discusses strengths, weaknesses, opportunities and threats affecting the biosimilar monoclonal antibodies market Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________

BiosimilarAntibody

100 Deals associated with Bevacizumab biosimilar(Fujifilm Kyowa Kirin Biologics Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Colonic Cancer	European Union	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Colonic Cancer	Iceland	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Colonic Cancer	Liechtenstein	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Colonic Cancer	Norway	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Fallopian Tube Carcinoma	European Union	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Fallopian Tube Carcinoma	Iceland	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Fallopian Tube Carcinoma	Liechtenstein	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Fallopian Tube Carcinoma	Norway	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Metastatic breast cancer	European Union	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Metastatic breast cancer	Iceland	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Metastatic breast cancer	Liechtenstein	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Metastatic breast cancer	Norway	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Non-Small Cell Lung Cancer	European Union	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Non-Small Cell Lung Cancer	Iceland	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Non-Small Cell Lung Cancer	Liechtenstein	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Non-Small Cell Lung Cancer	Norway	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Ovarian Epithelial Carcinoma	European Union	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Ovarian Epithelial Carcinoma	Iceland	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Ovarian Epithelial Carcinoma	Liechtenstein	Centus Biotherapeutics Europe Ltd.	24 Sep 2020
Ovarian Epithelial Carcinoma	Norway	Centus Biotherapeutics Europe Ltd.	24 Sep 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Phase 3	United States	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Japan	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Belarus	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Bosnia and Herzegovina	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Bulgaria	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Croatia	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Georgia	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Germany	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Greece	Centus Biotherapeutics Ltd.	07 Sep 2016
Non-squamous non-small cell lung cancer	Phase 3	Hungary	Centus Biotherapeutics Ltd.	07 Sep 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02810457 (Pubmed \| BioDrugs) Manual	Phase 3	Non-squamous non-small cell lung cancer	731	FKB238	btknbxhfmk(rduzcitbzs) = zkeeyxfksu yymrozwutz (eqrggfesnm ) View more	Similar	01 Jul 2021
				Bevacizumab	btknbxhfmk(rduzcitbzs) = qbvgmxdqcc yymrozwutz (eqrggfesnm ) View more
NCT02810457 (AVANA, CTgov)	Phase 3	Recurrent Lung Non-Squamous Non-Small Cell Carcinoma \| Non-squamous non-small cell lung cancer	731	Carboplatin+FKB238 (bevacizumab)+Paclitaxel (FKB238 / Paclitaxel / Carboplatin)	yitzdxvbwf = jbakwkevig jwncdvciut (lzevudwryz, mnkdxsbnkw - rztbqaigdf) View more	-	19 Mar 2020
				Carboplatin+Paclitaxel+Avastin (bevacizumab) (Avastin / Paclitaxel / Carboplatin)	yitzdxvbwf = bxseijvqvk jwncdvciut (lzevudwryz, fnwjsrehwk - nxsrdkhqkc) View more

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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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