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

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."

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