CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma

Inactive Indication-

Originator Organization

Biocad Medical, Inc.

Active Organization

Biocad Medical, Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Russia (01 Jan 2015),

Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma

Regulation-

Structure/Sequence

Sequence Code 27145L

The sequence is quoted from: *****

Sequence Code 83181H

The sequence is quoted from: *****

Clinical Trials associated with Rituximab biosimilar(Biocad Medical, Inc.)

NCT02744196

/ CompletedPhase 3

Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.

Start Date01 Jan 2015

Sponsor / Collaborator

Biocad CJSC

CTRI/2012/10/003048

/ CompletedPhase 3

A multicenter open-label randomized study of BCD-020 (rituximab, CJSC BIOCAD, Russia) efficacy and safety in comparison with MabTheraÂ® (F. Hoffmann-La Roche Ltd., Switzerland) in monotherapy of CD20-positive indolent non-Hodgkin lymphoma

Start Date16 Oct 2012

Sponsor / Collaborator-

100 Clinical Results associated with Rituximab biosimilar(Biocad Medical, Inc.)

100 Translational Medicine associated with Rituximab biosimilar(Biocad Medical, Inc.)

100 Patents (Medical) associated with Rituximab biosimilar(Biocad Medical, Inc.)

Literatures (Medical) associated with Rituximab biosimilar(Biocad Medical, Inc.)

01 Aug 2024·Doklady Biochemistry and Biophysics

The Use of “Acellbia”—A Biosimilar of Rituximab in Systemic Sclerosis

Article

Author: Ananyeva, L P ; Desinova, O V ; Nasonov, E L ; Glukhova, S I ; Koneva, O A ; Shayakhmetova, R U ; Ovsyannikova, O B ; Garzanova, L A ; Starovoitova, M N

The possibilities of modern therapy for systemic sclerosis (SSc) remains limited, since most of the used drugs do not have a disease-modifying effect. This encourages the study of new approaches that potentially affect the fundamental pathological processes underlying the disease. One example is anti-B-cell therapy, in particular rituximab (RTX). Until now RTX does not have a registration for the treatment of SSc, but there is a large positive experience of its use, which is reflected in recent meta-analyses and clinical recommendations. Complicated and expensive methods for obtaining genetically engineered biological drugs (biologics) have contributed to the emergence of more accessible biosimilars, one of which is the RTX biosimilar, Acellbia (Biocad, Russian Federation). The ''biosimilar'' versions of RTX might reduce the cost of therapy and increase patients accessibility to this treatment option. The RTX biosimilar Acellbia (ACB) has received approval in Russian Federation in 2014 for all indications held by reference RTX (including rheumatoid arthritis and ANCA-associated vasculitis).

01 Jan 2020·European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.VQ2 · MEDICINE

Multifaceted assessment of rituximab biosimilarity: The impact of glycan microheterogeneity on Fc function

Q2 · MEDICINE

Article

Author: Coghlan, Jill ; Saveliev, Sergei ; Hageman, Tyler S ; Schwendeman, Steven P ; Ruotolo, Brandon T ; Tolbert, Thomas J ; Vallejo, Daniel ; Sen, K Ilker ; Ford, Michael ; Kang, Jukyung ; White, Derek R ; Kim, Sang Yeop ; Schwendeman, Anna ; Weis, David D ; Benet, Alexander

Biosimilars are poised to reduce prices and increase patient access to expensive, but highly effective biologic products. However, questions still remain about the degree of similarity and scarcity of information on biosimilar products from outside of the US/EU in the public domain. Thus, as an independent entity, we performed a comparative analysis between the innovator, Rituxan® (manufactured by Genentech/Roche), and a Russian rituximab biosimilar, Acellbia® (manufactured by Biocad). We evaluated biosimilarity of these two products by a variety of state-of-the-art analytical mass spectrometry techniques, including tandem MS mapping, HX-MS, IM-MS, and intact MS. Both were found to be generally similar regarding primary and higher order structure, though differences were identified in terms of glycoform distribution levels of C-terminal Lys, N-terminal pyroGlu, charge variants and soluble aggregates. Notably, we confirmed that the biosimilar had a higher level of afucosylated glycans, resulting in a stronger FcγIIIa binding affinity and increased ADCC activity. Taken together, our work provides a comprehensive comparison of Rituxan® and Acellbia®.

01 May 2018·Clinical therapeuticsQ4 · MEDICINE

Monoclonal Antibody Biosimilars in Oncology: Critical Appraisal of Available Data on Switching

Q4 · MEDICINE

Article

Author: Zintzaras, Elias ; Bakalos, Georgios ; Declerck, Paul ; Barton, Bettina ; Schreitmüller, Thomas

PURPOSE:

With the introduction of biosimilars of anticancer monoclonal antibodies (mAbs) in oncology, physicians are potentially confronted with the question whether it is clinically adequate to switch patients who are clinically stable on treatment with the reference product to a newly available biosimilar (or vice versa/from 1 biosimilar to another). For a proper impact assessment of switching, robust, product-specific, and clinically relevant evidence should be required, ideally including data from appropriately designed switching studies. In this article, we assess the current body of switching data available for approved or proposed biosimilars of anticancer mAbs.

METHODS:

PubMed was systematically searched and ClinicalTrials.gov and abstract databases of selected congresses were hand-searched to identify all switching studies including biosimilars of anticancer mAbs.

FINDINGS:

We identified 8 switching studies with biosimilars of rituximab (CT-P10, GP2013, PF-05280586, and BCD-020) and trastuzumab (ABP 980). Two were performed in oncology indications and the other 6 in rheumatoid arthritis (RA). Key elements of a well-designed switching study, such as randomization and blinding, were contained in several of the studies, but significant limitations were also present. The most frequent limitations were low statistical power because of small patient numbers, lack of an appropriate control arm, short follow-up, chosen outcome measures, and (for studies performed in RA) the concern whether switching data can be extrapolated to oncology indications. Accordingly, the data from these studies need to be interpreted with caution. Of note, all identified studies included a single switch only, whereas multiple switches may occur in the real-world setting. The scientific need to evaluate the impact of repeated switching has been recognized by the US Food and Drug Administration, who incorporated such a requirement in its draft guidance on interchangeability.

IMPLICATIONS:

From the scarce data available, the consequences of switching between reference product mAbs and their biosimilar(s) in the oncology setting are as yet unknown. Additional clinical evidence from well-designed switching studies is needed to guide switching decisions.

News (Medical) associated with Rituximab biosimilar(Biocad Medical, Inc.)

17 Aug 2023

·www.pharmaceutical-technology.com

FDA approves Artiva’s AlloNK and rituximab combo IND to treat SLE

AlloNK plus rituximab is intended to treat systemic lupus erythematosus in patients with active lupus nephritis. Credit: mi_viri / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Artiva Biotherapeutics’ investigational new drug (IND) application for the combination of AlloNK (AB-101) and rituximab to treat systemic lupus erythematosus (SLE) in active lupus nephritis (LN) patients. Designed to improve antibody-dependent cellular cytotoxicity (ADCC), AlloNK is a non-genetically modified, allogeneic, cord blood-derived, cryopreserved NK cell therapy candidate. Recommended Reports Reports LOA and PTSR Model - (Cannabidiol + Dronabinol) in Sedation GlobalData Reports LOA and PTSR Model - Siremadlin Succinate in Well Differentiated Liposarcoma GlobalData View all Companies Intelligence Artiva Biotherapeutics Inc View all AlloNK is currently under assessment in two cancer trials, where it is being studied alongside antibody or NK-engager biologics. In May 2022 the company revealed preliminary results from the dose-escalation stage of its Phase I/II clinical trial involving AB-101. The trial, which focused on patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL), showed AlloNK’s therapeutic potential and favourable safety profile when used in conjunction with rituximab. Artiva CEO Fred Aslan stated: “AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B-cells, is already driving complete responses in late line B-NHL patients in an ongoing Phase I study by enhancing the activity of rituximab. “Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in LN patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.” SLE is a severe autoimmune condition characterised by faulty B-cell activity and production of autoantibodies. Its clinical symptoms include end-organ damage and increased risk of death. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Phase 1Drug ApprovalCell TherapyImmunotherapyGene Therapy

100 Deals associated with Rituximab biosimilar(Biocad Medical, Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Russia	Biocad Medical, Inc.	01 Jan 2015
Non-Hodgkin Lymphoma	Russia	Biocad Medical, Inc.	01 Jan 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2016	Phase 3	Rheumatoid Arthritis	160	BCD-020	dthrunycxi(doqzlvqery) = ypbkkgpgdy vypybxwpzu (adnqwkhzgf )	-	08 Jun 2016
				Innovator RTX	dthrunycxi(doqzlvqery) = gacadhflwa vypybxwpzu (adnqwkhzgf )

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