LusiNEX (tocilizumab biosimilar) / Gedeon Richter, Mochida - LARVOL DELTA

Comparison of the PK, PD, safety, tolerability, and immunogenicity of proposed biosimilar RGB-19 and tocilizumab in healthy Japanese males: a phase 1, randomised, crossover study. (PubMed, EULAR Rheumatol Open) - "This study demonstrated equivalence in PK and similarity in PD, immunogenicity, and safety of RGB-19 and tocilizumab. These data suggest RGB-19 provides a similar therapeutic benefit to tocilizumab."

Journal • P1 data

Efficacy, safety, and immunogenicity of proposed biosimilar RGB-19 and tocilizumab intravenously administered to adults with active rheumatoid arthritis and an inadequate response to methotrexate: a phase 3, randomised study. (PubMed, EULAR Rheumatol Open) - "The incidence of treatment-emergent antidrug and neutralising antibodies was similarly low in both groups. This study demonstrated equivalent efficacy, and similar safety and immunogenicity, of RGB-19 and reference tocilizumab for participants with active RA."

Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • IL6R

Announcement of Manufacturing and Marketing Approval for Tocilizumab BS MA in Japan (Mochida Pharmaceutical Co. Ltd Press Release) - "Mochida Pharmaceutical Co., Ltd...and AYUMI Pharmaceutical Corporation...announce that today Mochida obtained manufacturing and marketing approval for Tocilizumab BS MA (development code: RGB-19; hereinafter 'the Product') in Japan...Under the collaboration agreement between Mochida and AYUMI concerning domestic commercialization of the Product, Mochida will supply the Product to AYUMI, and AYUMI will be responsible for sales."

Japan approval • Launch Japan • Rheumatoid Arthritis

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026 (European Medicines Agency) - "On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tuyory, intended for the treatment of rheumatoid arthritis (RA), coronavirus disease 2019 (COVID-19), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), CAR-T cell-induced severe or life-threatening cytokine release syndrome (CRS), and giant cell arteritis (GCA)."

CHMP • Giant Cell Arteritis • Idiopathic Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis

Immunogenicity assay supporting clinical development of RGB-19, a proposed biosimilar to RoActemra®. (PubMed, Bioanalysis) - "To mitigate target interference, sarilumab - a high-affinity anti-sIL-6R antibody - was incorporated into the sample preparation. 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. https://jrct.mhlw.go.jp.Identifiers are: jRCT2031230029 and jRCT2031220512."

Journal • IL6

Phase 3 Study of the Efficacy, Safety and Immunogenicity of the Proposed Tocilizumab Biosimilar RGB-19, Intravenously Administered to Participants With Active Rheumatoid Arthritis: 52-Week Data (ACR Convergence 2025) - "Results of a Phase 3 study (jRCT2031220512) assessing the clinical equivalence in efficacy between RGB-19 and reference tocilizumab at Week 12, and comparing secondary efficacy, safety and immunogenicity outcomes up to Week 24, have been previously reported.1 Here, secondary outcomes up to Week 52 (safety to Week 54) are reported. This Phase 3, randomized, double-blind study enrolled Japanese adults with active rheumatoid arthritis and an inadequate response to methotrexate, a baseline Disease Activity Score based on 28 joints with erythrocyte sedimentation rate (DAS28-ESR) of ≥3.2, and swollen/tender joints (≥6 from 66/68). Similar efficacy, serum drug concentration, PD, safety and immunogenicity outcomes were shown for RGB-19 and tocilizumab up to the end of this Phase 3 study. These results support previously reported data that demonstrated the clinical equivalence in efficacy at Week 12 and similarity in secondary outcomes between treatments at Week 24.1Reference1...."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • IL6

Comprehensive Physico-Chemical and Functional Similarity Assessment of Intravenous and Subcutaneous RGB-19 Drug Products as Proposed Biosimilars to Tocilizumab Reference Product. (PubMed, BioDrugs) - "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."

Journal • IL6R

PHARMACOKINETIC, PHARMACODYNAMIC, SAFETY AND IMMUNOGENICITY EVALUATION OF THE PROPOSED TOCILIZUMAB BIOSIMILAR RGB-19 SUBCUTANEOUSLY ADMINISTERED TO HEALTHY MALE PARTICIPANTS: A PHASE 1, RANDOMISED, SINGLE-DOSE CROSS-OVER STUDY (EULAR 2025) - "In this study, PK equivalence of the proposed biosimilar RGB-19 was demonstrated, with comparable PD, safety, tolerability and immunogenicity to that of reference tocilizumab."

Clinical • P1 data • PK/PD data • Infectious Disease • IL6

Efficacy, safety and immunogenicity of the proposed tocilizumab biosimilar RGB-19, intravenously administered to participants with active rheumatoid arthritis: Week 24 data from a Phase 3 study (EULAR 2025) - " This was a Phase 3, randomised, double-blind study in Japanese adults with active RA and an inadequate response to methotrexate, a baseline Disease Activity Score based on 28 joints with erythrocyte sedimentation rate (DAS28-ESR) of ≥3.2, and swollen/tender joints (≥6 from 66/68). Equivalence in efficacy was shown between RGB-19 and tocilizumab. Serum drug concentration, PD, safety, and immunogenicity profiles were similar between treatments. Additional, longer-term efficacy, safety and immunogenicity outcomes up to W52 are anticipated."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • IL6

Description of a new Kurixalus species (Rhacophoridae, Anura) and a northwards range extension of the genus. (PubMed, Zookeys) - "We named the species described here as Kurixalusinexpectatus sp...due to the nature of the discovery, as well as the adjunct distribution of the species relative to its closest congeners. The species was found in Zhejiang Province and it represents a range extension of 663 km for the Kurixalus genus."

Journal