Delving into the Latest Updates on Bevacizumab biosimilar (mAbxience) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

AlymsysTM, Bevacizumab Biosimilar (mAbxience Research SL), Bevax

+ [9]

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

Non-squamous non-small cell lung cancerUterine Cervical CancerMetastatic Colorectal Carcinoma+ [15]

Inactive Indication

Squamous non-small cell lung cancer

Originator Organization

mAbxience Research SL

Active Organization

Libbs Farmacêutica Ltda.mAbxience Research SLAmneal Pharmaceuticals LLC

Inactive Organization-

License Organization

Libbs Farmacêutica Ltda.Amneal Intermediate, Inc.

STADA Arzneimittel AG

+ [2]

Drug Highest PhaseApproved

First Approval Date

European Union (26 Mar 2021),

Advanced Lung Non-Small Cell CarcinomaColonic CancerFallopian Tube Carcinoma+ [12]

Regulation-

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Structure/Sequence

Sequence Code 41632H

The sequence is quoted from: *****

Sequence Code 41637L

The sequence is quoted from: *****

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, safety and immunogenicity profile of MB02-DM with MB02-SP and US-Avastin® in healthy male subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Start Date11 Jan 2021

Sponsor / Collaborator

mAbxience Research SL

NCT04238663

/ CompletedPhase 1

A Randomised, Double Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar Drug), US Licenced Avastin® and EU Approved Avastin® in Healthy Male Volunteers

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Start Date24 Sep 2019

Sponsor / Collaborator

mAbxience Research SL

100 Clinical Results associated with Bevacizumab biosimilar (mAbxience)

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100 Translational Medicine associated with Bevacizumab biosimilar (mAbxience)

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100 Patents (Medical) associated with Bevacizumab biosimilar (mAbxience)

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9

Literatures (Medical) associated with Bevacizumab biosimilar (mAbxience)

01 Dec 2023·Pharmacology research & perspectives

Pooled analysis of three pharmacokinetic studies comparing biosimilar MB02 and reference bevacizumab

Article

Author: Paravisini, A. ; Miguel‐Lillo, B. ; Pérez Díaz, L. ; Sánchez‐Vidaurre, Sara

Abstract:

Aim:

The aim of this study was to add robustness and provide further evidence on the bioequivalence, safety and immunogenicity between MB02 and reference bevacizumab. No similar study has been performed before with a biosimilar monoclonal antibody.

Methods:

Population analysis by pooling data from three independent pharmacokinetic (PK) studies was performed. The studies had a single‐dose, double‐blind, three‐arm, parallel‐group design and two studies, MB02‐A‐02‐17 and MB02‐A‐05‐18, compared MB02 to EU‐ and US‐bevacizumab in Caucasian subjects, while study MB02‐A‐04‐18 compared MB02 and EU‐bevacizumab in Japanese participants. Primary endpoints included maximum observed serum concentration (Cmax), area under the serum concentration–time curve (AUC) from time zero and extrapolated to infinity (AUC0–∞) and AUC from time zero to the time of last quantifiable concentration (AUC0–t). Secondary endpoints included other PK parameters, safety and immunogenicity. A sensitivity analysis using actual protein concentration as a correction factor was applied to primary PK parameters.

Results:

Point estimates and 90% confidence intervals for the geometric mean ratios of primary PK parameters for MB02, EU‐ and US‐bevacizumab were all contained within the predefined bioequivalence margins (80%–125%) for all pairwise comparisons. The same results for all pairwise comparisons were observed when protein‐corrected primary PK parameters were analyzed. Safety and immunogenicity were similar between MB02 and the EU‐ and US‐reference bevacizumab in healthy subjects.

Conclusions:

This pooled analysis of three comparable PK studies further supports the bioequivalence of biosimilar MB02 to EU‐ and US‐reference bevacizumab. No clinically meaningful differences in safety or immunogenicity were observed.

01 Apr 2023·Pharmacology research & perspectives

A randomized, double‐blind, single‐dose study to assess bioequivalence of MB02 biosimilar after manufacturing iteration and reference bevacizumab

Article

Author: Florez‐Igual, A. ; Schwabe, C. ; Espigares‐Correa, A. ; Beydon, M. E. ; Queiruga‐Parada, J. ; Cole, A.

Abstract:

To investigate and compare the pharmacokinetic (PK) profiles of MB02 products, before and after optimizing the manufacturing process, and reference bevacizumab to establish bioequivalence between them. In this randomized, double‐blind, single dose, parallel study, 114 healthy male volunteers were randomized 1:1:1 to receive a 1 mg/kg intravenous dose of MB02‐SP, MB02‐DM, or US‐bevacizumab. The follow‐up period was 100 days. PK similarity between them was determined using the standard bioequivalence criteria (0.80–1.25) for the area under the serum concentration–time curve from time 0 extrapolated to infinity and the maximum observed serum concentration. Study results showed that the PK profiles of bevacizumab were similar. Statistical analysis demonstrated that for each pairwise comparison there were no differences. The 90% CIs for the ratios of geometric least squares means were fully contained within the predefined similarity acceptance limits and ranged from 0.899 to 1.12 for area under the curve and from 0.887 to 1.11 for maximum concentration. A total of 159 adverse events were reported by 76 subjects who received the study drug. The majority (90.6%) of the reported adverse events were grade 1 in severity, with 9.4% as grade 2 in severity. None were considered as grade 3, 4, or 5. Treatment‐induced anti‐drug antibodies incidence was 21.6%, 33.3%, and 23.7% for the treatment of MB02‐SP, MB02‐DM, and US‐bevacizumab, respectively. No subjects showed treatment‐induced neutralizing anti‐drug antibodies. This study demonstrates the PK, safety, and immunogenicity similarity and bioequivalence of MB02‐SP, MB02‐DM, and the reference product bevacizumab.

01 Jun 2022·Biologicals : journal of the International Association of Biological Standardization

Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization

Article

Author: Daniel Sacristán ; Koen Sandra ; Laxmi Adhikary ; Alexia Ortiz ; Clea Solís ; Marie-Elise Beydon ; Isabel Vandenheede ; Isabel Ruppen

The majority of recombinant mAb products contain heterogeneous charge variants, commonly the result of post-translational modifications occurring during cell culture and accumulated during production, formulation and storage. MB02 is a biosimilar mAb to bevacizumab. Similarity data of charge variants for biosimilars against its reference products must be generated to demonstrate consistency in product quality and to ensure efficacy and safety. The goal of this work was to isolate seven charge variants of MB02 and Avastin® by semi-preparative cation exchange chromatography followed by purity test and extended analytical characterization to prove similarity. Although poor purity obtained for minor variants complicated data interpretation, an in-depth insight into the charge variants pattern of MB02 compared to Avastin® was obtained, contributing to a better understanding of modifications associated to microheterogeneity. To our knowledge, this is the first comparative analytical study of individual charge variants of a bevacizumab biosimilar following a head-to head approach and the most comprehensive N-glycosylation assessment of IgG1 charge variants. Although modifications related to N- and C-terminal, N-glycans, size heterogeneity or deamidation were specifically enriched among low abundant charge variants, they did not affect binding affinity to VEGF or FcRn and in vitro potency compared with the main species or unfractionated material.

10

News (Medical) associated with Bevacizumab biosimilar (mAbxience)

10 Apr 2026

·www.fiercepharma.com

FDA accuses Amneal, BioCorRx of producing ‘false and misleading’ drug promos

Promotional materials for Lucemyra and Alymsys have come under the OPDP's scrutiny. Amneal and BioCorRx have earned the ire of the FDA’s Office of Prescription Drug Promotion (OPDP), with both being hit by accusations of violating the agency’s drug marketing rules. The two pharmas received separate untitled letters from the U.S regulator detailing the offenses in late March, with both published on the FDA’s site on April 9. The letter (PDF) to BioCorRx centers on the consumer webpage for the company’s Lucemyra (lofexidine), a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal.The FDA said that the drug’s “webpage is false or misleading [and] misbrands Lucemyra.” The misbranding comes from the site’s assertion that Lucemyra is “the only FDA-approved, non-opioid medicine proven to help with symptoms of opioid withdrawal.”The FDA points out that it has in fact green lit other lofexidine products in the same indication. The regulator also took umbrage with the company’s decision to highlight 2020 guidance from the American Society of Addiction Medicine in large bolded font. The guidance states that lofexidine “should therefore be the preferred choice for withdrawal management in an outpatient setting, where monitoring of blood pressure and management of hypotension is more difficult.” But the FDA points out that in contrast, the med’s full risk information is “only presented separately under the header, ‘Click to see full Important Safety Information & Prescribing Information,’ with lesser prominence.”The OPDP noted in its letter that: “The overall effect of this presentation undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Lucemyra.”The other letter (PDF) was for Amneal and its drug Alymsys (bevacizumab-maly), a biosimilar to Roche’s oncology drug Avastin. Specifically, the OPDP said a direct-to-consumer patient brochure was “misleading” as it didn’t show Alymsys’s full FDA-approved indications. “The presentations of the indications for Alymsys omit specific patient populations as well as its specific administration in combination with other chemotherapies,” the OPDP found. The letter also details the brochure’s failure to “disclose material risk information regarding the serious risks associated with Alymsys,” which includes cause fetal harm when administered to pregnant women, as well as minimizing other risk factors. This includes an assertion that all patients can expect that their side effects will resolve over time, “when this is not the case,” the FDA said. Both companies were given 15 days on receipt of their letters to respond and come up with a plan to deal with the promotional violations.

04 Mar 2025

·pipelinereview.com

Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

Denosumab biosimilar candidates reference Prolia ® and XGEVA ® Amneal looks to expand portfolio to six biosimilars across eight product presentations by 2027 BRIDGEWATER, NJ, USA I March 03, 2025 I Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience (“mAbxience”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia ® and XGEVA ® . mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius. The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. Under the terms of the agreement, mAbxience is responsible for the development and manufacturing of the biosimilars while Amneal will pursue regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience currently partner on ALYMSYS ® , a bevacizumab biosimilar, which was launched in 2022. “Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics. Building on our first three successful biosimilar launches, we look to expand our portfolio next with denosumab, which is an important therapy across multiple indications, including oncology. We are pleased to expand our partnership with mAbxience as we advance our biosimilars pipeline,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. “We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization strategy and applying innovation and cutting-edge R&D technology to create high quality, affordable medicines for underserved patients,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience. Prolia ® : In patients with postmenopausal osteoporosis, the most frequently reported adverse reactions included back musculoskeletal and extremity pain; hypercholesterolemia; and cystitis. Among male patients with osteoporosis, back pain, arthralgia, and nasopharyngitis were reported. Prolia also carries a Boxed Warning for patients with advanced chronic kidney disease. XGEVA ® : The most frequently reported serious adverse reaction was dyspnea. Other reported adverse reactions observed included fatigue, asthenia, hypophosphatemia, and nausea. Discontinuation was reported in patients with osteonecrosis and hypocalcemia. According to IQVIA ® , U.S. annual sales for Prolia ® and XGEVA ® for the 12 months ended December 2024 were approximately $5.0 billion. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn . About mAbxience mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website ( www.mabxience.com ) or connect with us on LinkedIn . SOURCE: Amneal Pharmaceuticals

License out/inAcquisitionDrug Approval

03 Mar 2025

·www.businesswire.com

Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience (“mAbxience”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia® and XGEVA®. mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius. The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. Under the terms of the agreement, mAbxience is responsible for the development and manufacturing of the biosimilars while Amneal will pursue regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience currently partner on ALYMSYS®, a bevacizumab biosimilar, which was launched in 2022. “Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics. Building on our first three successful biosimilar launches, we look to expand our portfolio next with denosumab, which is an important therapy across multiple indications, including oncology. We are pleased to expand our partnership with mAbxience as we advance our biosimilars pipeline,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. “We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization strategy and applying innovation and cutting-edge R&D technology to create high quality, affordable medicines for underserved patients,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience. Prolia®: In patients with postmenopausal osteoporosis, the most frequently reported adverse reactions included back musculoskeletal and extremity pain; hypercholesterolemia; and cystitis. Among male patients with osteoporosis, back pain, arthralgia, and nasopharyngitis were reported. Prolia also carries a Boxed Warning for patients with advanced chronic kidney disease. XGEVA®: The most frequently reported serious adverse reaction was dyspnea. Other reported adverse reactions observed included fatigue, asthenia, hypophosphatemia, and nausea. Discontinuation was reported in patients with osteonecrosis and hypocalcemia. According to IQVIA®, U.S. annual sales for Prolia® and XGEVA® for the 12 months ended December 2024 were approximately $5.0 billion. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. About mAbxience mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website (www.mabxience.com) or connect with us on LinkedIn. Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

License out/inDrug ApprovalBiosimilar

100 Deals associated with Bevacizumab biosimilar (mAbxience)

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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
Non-squamous non-small cell lung cancer	Brazil	Libbs Farmacêutica Ltda.	04 May 2022
Uterine Cervical Cancer	Brazil	Libbs Farmacêutica Ltda.	04 May 2022
Metastatic Colorectal Carcinoma	United States	Amneal Pharmaceuticals LLC	13 Apr 2022
Advanced Lung Non-Small Cell Carcinoma	European Union	mAbxience Research SL	26 Mar 2021
Advanced Lung Non-Small Cell Carcinoma	Iceland	mAbxience Research SL	26 Mar 2021
Advanced Lung Non-Small Cell Carcinoma	Liechtenstein	mAbxience Research SL	26 Mar 2021
Advanced Lung Non-Small Cell Carcinoma	Norway	mAbxience Research SL	26 Mar 2021
Colonic Cancer	European Union	mAbxience Research SL	26 Mar 2021
Colonic Cancer	Iceland	mAbxience Research SL	26 Mar 2021
Colonic Cancer	Liechtenstein	mAbxience Research SL	26 Mar 2021
Colonic Cancer	Norway	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	European Union	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	Iceland	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	Liechtenstein	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	Norway	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	European Union	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	Iceland	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	Liechtenstein	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	Norway	mAbxience Research SL	26 Mar 2021
Metastatic Carcinoma to the Uterine Cervix	European Union	mAbxience Research SL	26 Mar 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous non-small cell lung cancer	Phase 3	United States	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Brazil	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Bulgaria	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Chile	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Greece	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Hungary	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	India	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Lebanon	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Malaysia	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	Mexico	mAbxience Research SL	06 Feb 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04408989 (CTgov)	Phase 1	-	114	MB02-SP (MB02-SP (Bevacizumab Biosimilar))	jmqcidrlsz(gvrwkottcf) = catdqvrlrz xnuduwrxbh (uanofyxnyx, 12.3) View more	-	19 Sep 2024
				MB02-DM (MB02-DM (Bevacizumab Biosimilar))	jmqcidrlsz(gvrwkottcf) = yaelkujzvm xnuduwrxbh (uanofyxnyx, 15.8) View more
NCT03296163 (STELLA, Pubmed) Manual	Phase 3	Non-Small Cell Lung Cancer First line	627	paclitaxel+carboplatin+MB02	lpedvbeioz(lovstokqks) = wizvmjlfip pvbvocbyed (noecuhslwk ) View more	Similar	01 Jul 2021
				paclitaxel+carboplatin+Bevacizumab	lpedvbeioz(lovstokqks) = dlwvinlkyj pvbvocbyed (noecuhslwk ) View more
NCT03296163 (Stella Trial, ASCO2021)	Phase 3	Squamous non-small cell lung cancer	627	MB02	mjizacbppl(stkpykzgfe): RD = -2.22 (95% CI, -10.54 to 6.1)	Positive	28 May 2021
				EU-bevacizumab
NCT03296163 (STELLA study \| Stella Trial \| STELLA, CTgov)	Phase 3	Squamous non-small cell lung cancer	627	Paclitaxel+Carboplatin+MB02 (Bevacizumab Biosimilar Drug) (MB02 (Bevacizumab Biosimilar Drug))	zfgvozgrbt = dsneosryma njtxxbjxzv (dbqgaewluf, zpxarwoscc - dfwslspuyv) View more	-	26 Mar 2021
				Paclitaxel+Carboplatin+Avastin (EU-approved Avastin®)	zfgvozgrbt = vckiqxyost njtxxbjxzv (dbqgaewluf, lzdwaksnmh - awkfuiogbp) View more
NCT04238663 (CTgov)	Phase 1	-	115	MB02 (Bevacizumab Biosimilar) (MB02 (Bevacizumab Biosimilar))	qcdbaehrkg(hxdxszargv) = syiyoeyvsd ybieqrhqsi (rsxaxdybha, 24.8) View more	-	24 Feb 2021
				EU approved Avastin® (EU Approved Avastin®)	qcdbaehrkg(hxdxszargv) = povmdfhyan ybieqrhqsi (rsxaxdybha, 20.0) View more
NCT04238650 (CTgov)	Phase 1	-	49	MB02 (Bevacizumab Biosimilar) (MB02 (Bevacizumab Biosimilar))	hmaqfjckda(mlhsbavadf) = jlnxcjijdo bzxducwhze (pntmkprpoa, 14.7) View more	-	01 Feb 2021
				EU approved Avastin® (EU Approved Avastin®)	hmaqfjckda(mlhsbavadf) = fqnuqwrhey bzxducwhze (pntmkprpoa, 10.8) View more
NCT03293654 (CTgov)	Phase 1	-	114	MB02 (MB02 (Bevacizumab Biosimilar))	xpghaeccfz(pnzszmmyvu) = tkbwekxmfx zjgxzutcpm (vybkamzwqj, 22.4) View more	-	16 Jun 2020
				US licenced Avastin® (US Licenced Avastin®)	xpghaeccfz(pnzszmmyvu) = afyxrcmwkh zjgxzutcpm (vybkamzwqj, 21.9) View more
NCT03296163 (STELLA study, ASCO2020)	Phase 3	Non-squamous non-small cell lung cancer	627	MB02	gawyrcxovj(mqeppmaepo): RR = 1.013 (90% CI, -0.037 to 0.059) View more	Positive	25 May 2020
				Bevacizumab
NCT02069704 (CTgov)	Phase 1	Metastatic Colorectal Carcinoma	142	Bevacizumab biosimilar (BEVZ92) (Bevacizumab Biosimilar (BEVZ92))	wiobwldrsd(zmbiohxuvj) = ygovqnabwg gjpziqjhkr (kbwwukmujv, 30.7) View more	-	23 Jul 2019
				Avastin+bevacizumab (Avastin® (Bevacizumab, Ref. Product))	kxcxfkksyc = nabrlqvqxy likfcvadce (wmxkeqrseb, qcrwhbxqlp - hnqdbhrmjw) View more
NCT02069704 (Pubmed \| Lancet Gastroenterol Hepatol) Manual	Phase 1	Colorectal Cancer First line	142	FOLFOX+FOLFIRI+BEVZ92	wjxacaexef(hhtutzsbqj): geometric mean ratio = 99.4 (90% CI, 90.5 - 109.0) View more	Similar	01 Dec 2018
				FOLFOX+FOLFIRI+bevacizumab

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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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Understand key drug designations in just a few clicks with Synapse.

Bevacizumab biosimilar (mAbxience)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation