This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.

Start Date21 Apr 2022

Sponsor / Collaborator

Laboratorios Liomont SA de CV

NCT04408989 / Unknown statusPhase 1

A Randomized, Double-Blind, Three-Arm, Single Dose, Parallel Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02-SP, MB02-DM (Bevacizumab Biosimilar Drugs)and US-licensed Avastin® in Healthy Male Volunteers

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 Date12 Aug 2020

Sponsor / Collaborator

mAbxience Research SL

JPRN-JapicCTI-205096 / CompletedPhase 1

A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a proposed bevacizumab biosimilar drug) and EU-approved Avastin in Japanese Healthy Male Volunteers

Start Date19 Sep 2019

Sponsor / Collaborator

mAbxience Research SL

100 Clinical Results associated with Bevacizumab biosimilar (mAbxience)

100 Translational Medicine associated with Bevacizumab biosimilar (mAbxience)

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

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 ; Sánchez-Vidaurre, Sara ; Pérez Díaz, L ; Miguel-Lillo, B

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.

03 Aug 2023·Animals : an open access journal from MDPI

In Silico and In Vitro Evaluation of Bevacizumab Biosimilar MB02 as an Antitumor Agent in Canine Mammary Carcinoma.

Article

Author: Fara, María Laura ; Alonso, Daniel F ; Lemos, Jesús S ; Benavente, Micaela A ; Hellmén, Eva ; Llavona, Candela ; Bucci, Paula L ; Cardama, Georgina A ; Medrano, Eduardo ; Demarco, Ignacio A ; Sabella, Patricia ; Spitzer, Eduardo ; Garona, Juan

Canine mammary carcinomas (CMC) are associated with major aggressive clinical behavior and high mortality. The current standard of care is based on surgical resection, without an established effective treatment scheme, highlighting the urgent need to develop novel effective therapies. Vascular endothelial growth factor (VEGF) is a key regulator of tumor angiogenesis and progression in the majority of solid cancers, including human and canine mammary carcinomas. The first therapy developed to target VEGF was bevacizumab, a recombinant humanized monoclonal antibody, which has already been approved as an anticancer agent in several human cancers. The goal of this work was to establish the therapeutic value of MB02 bevacizumab biosimilar in CMC. First, through different in silico approaches using the MUSCLE multiple-sequence alignment tool and the FoldX protein design algorithm, we were able to predict that canine VEGF is recognized by bevacizumab, after showing an extremely high sequence similarity between canine and human VEGF. Further, by using an ELISA-based in vitro binding assay, we confirmed that MB02 biosimilar was able to recognize canine VEGF. Additionally, canine VEGF-induced microvascular endothelial cell proliferation was inhibited in a concentration-dependent manner by MB02 biosimilar. These encouraging results show a high potential for MB02 as a promising therapeutic agent for the management of CMC.

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

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.

News (Medical) associated with Bevacizumab biosimilar (mAbxience)

12 Oct 2023

·www.biospace.com

Amneal Adds Two Denosumab Biosimilars to U.S. Pipeline, Expanding Oncology Portfolio

- Biosimilar candidates referencing Prolia® and XGEVA® - Builds on first year success of Amneal’s initial three biosimilar launches - Expands existing biosimilar partnership with mAbxience BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the addition of two denosumab biosimilars referencing both Prolia® and XGEVA® to its biosimilar pipeline. 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. The two denosumab products are being developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Under the terms of the agreement, mAbxience will fully develop the biosimilar molecule and manufacture it in its state-of-the-art, Good Manufacturing Practice (GMP)-approved facilities, while Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience also currently partner on ALYMSYS®, a bevacizumab biosimilar. “Our goal is to be a top five player in the U.S. biosimilar space, similar to our leadership position in U.S. retail generics. Biosimilars represent the next wave of affordable medicines and these new product opportunities are aligned with our strategy to provide high quality, essential therapies,” said Harsher Singh, Senior Vice President, Amneal Biosciences. “Our first three commercial U.S. biosimilars are doing very well as our excellent commercial team drives uptake in these competitive categories. We are pleased to partner again with mAbxience on these next two biosimilar candidates, which deepens our pipeline and expands our presence in oncology.” “We are thrilled to strengthen our partnership with Amneal through this second agreement, marking a significant step forward in our shared mission to enhance global health. This collaboration will bring two world-class biosimilars for the treatment of bone diseases and oncology to patients across the U.S., reinforcing our commitment to ensuring worldwide access to high-quality, life-enhancing treatments. Together with Amneal, we continue to make strides in offering affordable and accessible healthcare solutions, contributing positively to public health and solidifying our presence in the global biosimilar space,” said Emmanuelle Lepine, Chief Executive Officer, mAbxience. According to IQVIA®, U.S. annual sales for Prolia® and XGEVA® for the 12 months ended August 2023 were approximately $4.4 billion. The financial terms of the transaction were not disclosed, and any incremental expenses associated with these products are contemplated within Amneal’s guidance. About Amneal Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 pharmaceutical products, primarily within the United States. In its Generics 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, with a pipeline focused on unmet needs. 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 . 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, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, 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 reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. 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. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. 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/inBiosimilar

12 Oct 2022

·endpts.com

Additional manufacturers in short supply of generic Adderall

At the beginning of September, several manufacturers detailed a shortage of generic Adderall, otherwise known as amphetamine mixed salts, for a variety of dosage amounts. Now it appears that the shortage has reached more manufacturers. According to the American Society of Health-System Pharmacists (AHSP), shortages for the generic have hit a total of seven manufacturers for both extended and immediate-release capsules. For the immediate release version of the drug, shortages have been reported by the ASHP from manufacturers including Rhodes, Sandoz and Teva, in several dosage amounts, though none of the companies have reported the reasons behind the shortages. ASHP stated that Teva’s 10, 20 and 30 mg tablets are on backorder and the company estimates a release date for the middle of October or early- to mid-November. AHSP reported that Sandoz cannot estimate when they will have 10 and 30 mg doses available and Rhodes has 10, 20 and 30 mg doses in limited supply. The 5 and 15 mg doses are also on backorder and there is no confirmation as to when the drug will be available. However, Solco does have doses available at current. Shortages of the extended release capsules have been reported by several manufacturers including Amneal Pharmaceuticals, Camber Pharmaceuticals, Par Pharmaceuticals, Rhodes, Sun Pharma and Teva, with none of the companies providing additional details on the reason. Amneal has 15mg doses available. Several dosage amount are also in stock from Lannett, Prasco, Rhodes and Sandoz. The ASHP report shows that Amneal will release more in the 5, 10, 20, 25 and 30 mg dosage amounts sometime this month, while Teva will release supplies as they become available. The rest cannot give a release date at this time, according to the report. Endpoints News reached out to all the companies involved. Camber and Amneal declined to comment on the matter and Endpoints did not receive comment from the other manufacturers. Generic Adderall shortages continue as several manufacturers stare down supply squeezes In early September, Teva, Amneal, Purdue subsidiary Rhodes Pharmaceuticals and Sandoz were the only ones looking at shortages, according to the ASHP. The current Adderall squeeze, according to a report from Bloomberg , may be caused in part by a rise in prescriptions. This is due to a combination of factors such as increased dosage amounts and wider availability through startup prescription services. Earlier this year the FDA also sent a warning to two unregistered pharmacies accused of illegally selling Adderall online to customers without a prescription.

11 Oct 2022

·www.biospace.com

ImmunityBio Backslides while Rigel and Amneal also Reveal Job Cuts

Ten months after taking over a state-of-the-art facility in New York that was expected to expand the company’s manufacturing footprint, ImmunityBio announced job cuts at the site. Patrick Soon-Shiong’s ImmunityBio will lay off 38 employees at the Dunkirk site due to “economic” reasons, according to a WARN notice filed with the state of New York. The cuts began Sept. 29 and are expected to be completed by the end of the year. In January, ImmunityBio acquired the Dunkirk site from Athenex, Inc., which was in the process of scaling down operations following failure to win approval of a metastatic breast cancer treatment. Under terms of the deal with Athenex, ImmunityBio assumed responsibility for the investment and employment commitments made by Athenex with the state of New York in 2016 when it invested in the property. How or if the layoffs will impact that deal remains unknown at this point. A spokesperson for ImmunityBio told BioSpace the company conducted an in-depth review of the Dunkirk facility and determined the site “has construction needs” that are expected to take 12 to 18 months to complete. The needs will enable the site to be used as intended. “For this reason, we will need fewer employees during the construction period,” the spokesperson, who declined to be named, said. When ImmunityBio took over the Dunkirk site in January, the company announced it gained a 400,000 square-foot, state-of-the-art, finish-fill and lyophilization facility. The site was expected to be able to provide 1 billion doses of RNA and adjuvant vaccine production. ImmunityBio also noted it gained clean rooms that can expedite the large-scale manufacture of self-amplifying RNA and second-generation DNA COVID-19 vaccine platforms. ImmunityBio also intended further investments in the plant to add “state-of-the-art biological manufacturing equipment and transferring technology” that will allow it to produce COVID-19 vaccine substance by the fourth quarter of this year, the company announced at the time. ImmunityBio isn’t the only company to announce job cuts. Amneal to Close Long Island Plant Amneal Pharmaceuticals is shuttering a facility in Long Island, N.Y. The first 13 employees at the site have already been notified of their termination, which will be effective before the end of the year, according to a WARN notice filed with the state Sept. 28. The Long Island facility currently employs 89 individuals. After the 13 depart, the company said the remaining 76 employees are expected to continue working at the site through March of next year when the plant will be closed. Amneal has been on a roll this year with two biosimilar drugs approved by the FDA. The company won approval for Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Amgen’s Neupogen. It also received the green light for Alymsys (bevacizumab-maly), a biosimilar to Genentech’s Avastin. Rigel Culls 30 Employees Following guidance from the FDA, Bay Area-based Rigel Pharmaceuticals will not supplemental New Drug Application for fostamatinib as a potential treatment for patients with warm autoimmune hemolytic anemia (wAIHA). The company will continue to explore options for this program, it announced Monday. At the same time, Rigel reported it will cut its headcount by 16%, eliminating 30 positions. The jobs being eliminated are primarily in development and administration, the company announced. Raul Rodriguez, president and chief executive officer of Rigel, called the cuts an appropriate action that will enable the company to focus on near-term opportunities with its fostamatinib, olutasidenib and IRAK 1/4 programs. The job cuts are expected to reduce annual operating expenses by $7 million, Rigel noted in its announcement. The company will pay out about $1.5 million in severance.

BiosimilarVaccine

100 Deals associated with Bevacizumab biosimilar (mAbxience)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	US	Amneal Pharmaceuticals LLC	13 Apr 2022
Advanced Lung Non-Small Cell Carcinoma	EU	mAbxience Research SL	26 Mar 2021
Advanced Lung Non-Small Cell Carcinoma	IS	mAbxience Research SL	26 Mar 2021
Advanced Lung Non-Small Cell Carcinoma	LI	mAbxience Research SL	26 Mar 2021
Advanced Lung Non-Small Cell Carcinoma	NO	mAbxience Research SL	26 Mar 2021
Colonic Cancer	EU	mAbxience Research SL	26 Mar 2021
Colonic Cancer	IS	mAbxience Research SL	26 Mar 2021
Colonic Cancer	LI	mAbxience Research SL	26 Mar 2021
Colonic Cancer	NO	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	EU	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	IS	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	LI	mAbxience Research SL	26 Mar 2021
Fallopian Tube Carcinoma	NO	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	EU	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	IS	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	LI	mAbxience Research SL	26 Mar 2021
Metastatic breast cancer	NO	mAbxience Research SL	26 Mar 2021
Metastatic Carcinoma to the Uterine Cervix	EU	mAbxience Research SL	26 Mar 2021
Metastatic Carcinoma to the Uterine Cervix	IS	mAbxience Research SL	26 Mar 2021
Metastatic Carcinoma to the Uterine Cervix	LI	mAbxience Research SL	26 Mar 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous non-small cell lung cancer	Phase 3	BR	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	BG	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	CL	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	GE	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	GR	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	HU	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	IN	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	LB	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	MY	mAbxience Research SL	06 Feb 2018
Squamous non-small cell lung cancer	Phase 3	MX	mAbxience Research SL	06 Feb 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03296163 (STELLA, Pubmed) Manual	Phase 3	Non-Small Cell Lung Cancer First line	627	paclitaxel+carboplatin+MB02	qgqxkgsmbu(sknjvdadjh) = qtfvqvbbtu hbnynhfojp (awkxvgotwf ) View more	Similar	01 Jul 2021
				paclitaxel+carboplatin+Bevacizumab	qgqxkgsmbu(sknjvdadjh) = dtgqluqwtt hbnynhfojp (awkxvgotwf ) View more
NCT03293654 (CTgov)	Phase 1	-	114	MB02 (MB02 (Bevacizumab Biosimilar))	oxnkoxrhre(vooinnzfbg) = sqovmwnsnj fcwkaziqxi (aeleqzzvsk, uyjeoleonk - apfxyscsvm) View more	-	16 Jun 2020
				US licenced Avastin® (US Licenced Avastin®)	oxnkoxrhre(vooinnzfbg) = fmxyoxxyvh fcwkaziqxi (aeleqzzvsk, ftaomsbuij - xotipyywjy) View more
NCT02069704 (Pubmed \| Lancet Gastroenterol Hepatol) Manual	Phase 1	Colorectal Cancer First line	142	FOLFOX+FOLFIRI+BEVZ92	tqkjntwfig(dkpnbcospz): geometric mean ratio = 99.4 (90% CI, 90.5 - 109.0) View more	Similar	01 Dec 2018
				FOLFOX+FOLFIRI+bevacizumab

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