Delving into the Latest Updates on Tocilizumab biosimilar (Mycenax Biotech) with Synapse

This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg in healthy volunteers (hereafter referred to as subjects). The therapeutic dose of tocilizumab starts with 4 mg/kg and ranges to 12 mg/kg, considering 4 mg/kg is the lowest dose, the same has been selected for the study.

Start Date17 Oct 2017

Sponsor / Collaborator

Mycenax Biotech, Inc.

100 Clinical Results associated with Tocilizumab biosimilar (Mycenax Biotech)

Login to view more data

100 Translational Medicine associated with Tocilizumab biosimilar (Mycenax Biotech)

Login to view more data

100 Patents (Medical) associated with Tocilizumab biosimilar (Mycenax Biotech)

Login to view more data

2

Literatures (Medical) associated with Tocilizumab biosimilar (Mycenax Biotech)

02 Dec 2025·Bioanalysis

Immunogenicity assay supporting clinical development of RGB-19, a proposed biosimilar to RoActemra®

Article

Author: Nagasawa, Katsuaki ; Uchida, Kazuya ; Kónya, Attila ; Tóth, János Pál

AIMS:

The aim of the work was to develop and validate an anti-drug antibody (ADA) assay for RGB-19, a proposed biosimilar to tocilizumab, capable of detecting anti-tocilizumab antibodies in the presence of high concentrations of soluble IL-6 receptor (sIL-6R), the drug's pharmacological target.

METHODS:

A bridging electrochemiluminescent immunoassay was applied. To mitigate target interference, sarilumab - a high-affinity anti-sIL-6R antibody - was incorporated into the sample preparation. The assay was validated per EMA and FDA guidelines.

RESULTS:

The assay demonstrated high sensitivity, robust precision, and selectivity across normal and diseased matrices. Drug tolerance exceeded 280 µg/mL at regulatory sensitivity thresholds, and target tolerance was confirmed up to 1000 ng/mL sIL-6R. Performance monitoring during Phase I and III clinical sample analysis confirmed stability and acceptable false-positive rates.

CONCLUSION:

The validated ADA assay effectively neutralized sIL-6R interference and provided reliable immunogenicity assessment for RGB-19 clinical trials. Its robustness supports biosimilarity evaluation and ensures compliance with regulatory standards. Validation of this ADA assay is essential for regulatory compliance and patient safety. By ensuring accurate ADA detection under clinically relevant conditions, it supports biosimilarity demonstration and streamlines regulatory review, ultimately facilitating timely access to cost-effective biologic therapies.

CLINICAL TRIAL REGISTRATION:

https://jrct.mhlw.go.jp.Identifiers are: jRCT2031230029 and jRCT2031220512.

BIODRUGS

Comprehensive Physico-Chemical and Functional Similarity Assessment of Intravenous and Subcutaneous RGB-19 Drug Products as Proposed Biosimilars to Tocilizumab Reference Product

Article

Author: Solti, Katalin ; Háda, Viktor ; Timári, Sarolta ; Hegedüs, Rózsa ; Pataj, Zoltán ; Faludi, Tamás ; Iliás, Attila

BACKGROUND AND OBJECTIVE:

Tocilizumab is a recombinant, humanised monoclonal antibody of the immunoglobulin G1 (IgG1) subclass, which specifically targets the interleukin-6 receptor (IL-6R). The RGB-19 product was developed as a biosimilar to the reference medicinal product RoActemra^® (authorised for use in the European Union [EU]). The current study focuses on the demonstration of structural, physico-chemical and functional similarity between RGB-19 (intravenous [IV] and subcutaneous [SC] presentations) and EU-sourced RoActemra^® (IV and SC presentations).

METHODS:

The RGB-19 biosimilar tocilizumab product was comprehensively tested using an extensive state-of-the-art analytical and functional panel of 44 methods to demonstrate similarity to the EU-sourced RoActemra^®. Biosimilarity was rigorously evaluated through an extensive array of orthogonal physico-chemical and functional assays, supplemented by a detailed comparative characterisation of the primary and higher order structures of the therapeutic proteins.

RESULTS:

Extensive structural analyses confirmed that the primary and higher order structures of tocilizumab proteins in RGB-19 IV and SC drug products are identical or exhibit a high degree of similarity to those of the RoActemra^® reference products. The impurity profiles of RGB-19 and RoActemra^® products were found to be highly comparable, as demonstrated by a series of physico-chemical techniques. A high level of similarity was shown for the most critical (soluble IL-6R binding and cell-based anti-proliferation assay) and for all other bioassay attributes. Based on the statistical evaluation, negligible differences could be detected for sialylation, glycation, fragments and charge variants, which do not affect the functional properties.

CONCLUSION:

Based on the similarity study, RGB-19 and RoActemra^® can be considered highly similar drug products. The minor differences found for some physico-chemical attributes do not affect the biological potency, binding and other critical attributes, and are therefore not considered clinically meaningful.

4

News (Medical) associated with Tocilizumab biosimilar (Mycenax Biotech)

04 Jun 2026

·www.biospace.com

Gedeon Richter Highlights Expanding Biosimilars Portfolio and Scientific Engagement at EULAR 2026

LONDON, UK / ACCESS Newswire / June 4, 2026 / The Biotechnology Business Unit of Gedeon Richter Plc. (Richter) is present at this year's European Alliance of Associations for Rheumatology's (EULAR) European Congress of Rheumatology, underlining its role as a growing contributor to biologic therapies in Europe. The company also hosted a satellite symposium on the opening day, as part of its engagement with the rheumatology community. Richter's presence at EULAR reflects nearly two decades of focused investment following its strategic entry into biotechnology. Today, it operates a fully integrated biosimilars business with a European development and manufacturing network, including facilities in Budapest and Debrecen in Hungary, operations in Germany, and global partnerships supported by over 1,000 biotech professionals. As part of its scientific program, yesterday Richter hosted the symposium "Prevention, better than treatment - insights on inflammatory joint disease and osteoporosis" chaired by Professor Paul Emery. The session addressed key aspects of disease management, including osteoporosis as an often overlooked dimension of rheumatoid arthritis, presented by Dr. Lothar Seefried, and the role of biologic therapies in achieving remission-driven outcomes, discussed by Professor James Galloway. "Richter's progress in biosimilars reflects our commitment to making biologic therapies more accessible to patients, while events such as EULAR and collaboration with leading experts remain essential to advancing care" said Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter. Building on its long-term strategy, Richter is establishing a rapidly expanding biosimilar portfolio across rheumatology, immunology, and osteoporosis. The company's portfolio includes the denosumab biosimilars Junod ® and Yaxwer ® , as well as its newest addition, the tocilizumab biosimilar Tuyory ® , strengthening Richter's presence in the treatment of chronic inflammatory conditions such as rheumatoid arthritis. Richter continues to progress its biosimilar pipeline, leveraging both in-house expertise and in-licensing opportunities. From its early biosimilar entry with Terrosa ® to today's broadening portfolio, Richter has consistently focused on developing high-quality biosimilar medicines to established biologics. Biosimilars can support healthcare systems by providing additional treatment options where approved and used in line with local guidance. Through its active participation at EULAR, Richter reaffirms its commitment to scientific exchange, innovation, and improving patient care across Europe and beyond. About Richter Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.8bn and sales of EUR 2.3bn in 2025, it operates Central Europe's largest R&D hub. Its research drives advances in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at For further information: Media: Zsuzsa Beke +36 20 916 4507 SOURCE: Gedeon Richter Plc. View the original press release on ACCESS Newswire

Biosimilar

27 Feb 2026

·allsci.com

CHMP gives approval recommendations for 12 drugs, including Moderna’s mRNA flu-COVID combo vaccine

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended 12 medicines for approval at its February 2026 meeting, including a first-in-class combined mRNA vaccine targeting both seasonal influenza and COVID-19. At the forefront, the CHMP recommended granting a marketing authorization for mCombriax, a combined influenza and COVID-19 mRNA vaccine developed by Moderna. Designed for adults aged 50 and older, mCombriax combines two messenger RNA constructs into a single formulation intended to simplify annual respiratory virus immunisation. The recommendation now goes to the European Commission for final approval. According to World Health Organization data, Europe has recorded more than 281 million COVID-19 cases since the pandemic began, while seasonal influenza alone causes up to 50 million symptomatic cases annually in the European Economic Area (EEA). In oncology, the CHMP recommended a conditional marketing authorisation for Ojemda (tovorafenib) for patients aged six months and older with pediatric low-grade glioma, a non-cancerous brain tumor. The once-weekly oral targeted therapy – developed by Day One Biopharmaceuticals, with ex-US rights licensed to Ipsen SA – aims to expand treatment options beyond surgery and conventional chemotherapy, which can have modest benefit and significant toxicity in young patients. The committee also adopted a positive opinion for Onerji, a levodopa/carbidopa product developed by Tanabe Pharma GmbH, for adults with advanced Parkinson’s disease. In endocrinology, Recordati Rare Diseases-partnered paltusotine, marketed as Palsonify by Crinetics Pharmaceuticals, received a positive opinion for acromegaly, a rare disorder of excess growth hormone. Immunology saw a positive opinion for Rhapsido (remibrutinib) from Novartis for chronic spontaneous urticaria, a long-term itchy rash. For rare inherited immune dysfunction, the CHMP adopted an opinion under exceptional circumstances for Xolremdi (mavorixafor) from X4 Pharmaceuticals, intended for patients aged 12 and older with WHIM syndrome, an ultra-rare condition marked by recurrent infections and increased malignancy risk. The committee also endorsed six biosimilar medicines. Among them was Poherdy, a pertuzumab biosimilar developed by Shanghai Henlius Biotech and partnered with Organon for global ex-China commercialization. If approved, Poherdy would be the first pertuzumab biosimilar endorsed by the CHMP, broadening competition to Roche’s reference product Perjeta in the EU. Poherdy was approved by the US FDA in November 2025. Additional biosimilars recommended include insulin lispro Bysumlog and insulin aspart Dazparda (both from Gan & Lee Pharmaceuticals, and marketed by Sandoz); etanercept Fubelv (by Biosimilar Collaborations Ireland); tocilizumab Tuyory (developed by Gedeon Richter in collaboration with Mochida Pharmaceutical); and teriparatide Zandoriah (by Cinnagen Co. Unipessoal Lda). Final marketing authorizations are subject to European Commission decisions, typically issued within two to three months following CHMP positive opinions.

Drug ApprovalVaccinemRNAImmunotherapyAccelerated Approval

28 Mar 2025

·pipelinereview.com

Richter Announces Submission to European Medicines Agency for Biosimilar Tocilizumab in Multiple Indications

March 27, 2025 I Gedeon Richter Plc. announces today that the European Medicines Agency has accepted Richter’s marketing authorization application (MAA) for its proposed biosimilar to RoActemra® tocilizumab – development code: RGB-19. Tocilizumab, the first biologic to inhibit IL-6 signaling, is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, cytokine release syndrome and COVID-19. Richter submitted a comprehensive analytical and clinical data package, which comprises data from a Phase I pharmacokinetic/pharmacodynamic (PK/PD) similarity study in healthy male volunteers and a multicenter efficacy and safety comparability Phase III study in patients with rheumatoid arthritis. According to the data package, Richter’s tocilizumab biosimilar matches the reference products in relation to PK, PD, efficacy, safety, and immunogenicity in the respective populations used in the studies. The data also contribute to the demonstration of similarity, which forms the basis for the biosimilar’s use in all indications of the originator’s product. RGB-19 has been developed jointly by Richter and Mochida Pharmaceutical Co., Ltd. “The submission of the tocilizumab biosimilar to the EMA is yet another milestone in building Richter’s affordable medicines portfolio. This biosimilar – when approved – will provide access to a broad range of our patients in Europe to this important biological drug” – said Dr. Erik Bogsch, Head of the Biotechnology Business Unit. About Gedeon Richter Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.7bn and sales of EUR 2.2bn in 2024, it operates Central Europe’s largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women’s Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com

Phase 3Clinical ResultPhase 1Drug Approval

100 Deals associated with Tocilizumab biosimilar (Mycenax Biotech)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC07	-

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Castleman Disease	Japan	Mochida Pharmaceutical Co., Ltd.	01 Jun 2026
COVID-19	European Union	Chemical Works of Gedeon Richter Plc	27 Apr 2026
COVID-19	Iceland	Chemical Works of Gedeon Richter Plc	27 Apr 2026
COVID-19	Liechtenstein	Chemical Works of Gedeon Richter Plc	27 Apr 2026
COVID-19	Norway	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Cytokine Release Syndrome	European Union	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Cytokine Release Syndrome	Iceland	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Cytokine Release Syndrome	Liechtenstein	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Cytokine Release Syndrome	Norway	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Polyarticular Juvenile Idiopathic Arthritis	European Union	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Polyarticular Juvenile Idiopathic Arthritis	Iceland	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Polyarticular Juvenile Idiopathic Arthritis	Liechtenstein	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Polyarticular Juvenile Idiopathic Arthritis	Norway	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Rheumatoid Arthritis	European Union	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Rheumatoid Arthritis	Iceland	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Rheumatoid Arthritis	Liechtenstein	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Rheumatoid Arthritis	Norway	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Systemic onset juvenile chronic arthritis	European Union	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Systemic onset juvenile chronic arthritis	Iceland	Chemical Works of Gedeon Richter Plc	27 Apr 2026
Systemic onset juvenile chronic arthritis	Liechtenstein	Chemical Works of Gedeon Richter Plc	27 Apr 2026

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Giant Cell Arteritis	NDA/BLA	European Union	Chemical Works of Gedeon Richter Plc	26 Feb 2026

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-jRCT2031220512 (ACR2025)	Phase 3	Rheumatoid Arthritis	368	RGB-19 8 mg/kg	ksjrhnzxrf(hahwdspxmw) = vztrlfadpd wbwtzbilsc (hgpvkafghq )	Similar	24 Oct 2025
				Tocilizumab 8 mg/kg	ksjrhnzxrf(hahwdspxmw) = rnxarrdnzv wbwtzbilsc (hgpvkafghq )

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

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.

login

or

view full example data