Elizaria (eculizumab biosimilar) / Generium - LARVOL DELTA

RESULTS OF LONG-TERM THERAPY WITH A BIOSIMILAR OF ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA. (PubMed, Acta Haematol) - "The study findings confirm the long-term efficacy and safety of biosimilar in patients with PNH."

Journal • Alopecia • Chronic Kidney Disease • Complement-mediated Rare Disorders • Hematological Disorders • Immunology • Nephrology • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Renal Disease

The Features of COVID-19's Course and the Efficacy of the Gam-COVID-Vac Vaccine in Patients with Paroxysmal Nocturnal Hemoglobinuria. (PubMed, Hematol Rep) - "The study included data from 52 patients with PNH aged 18 to 75 years, 38 of whom received background therapy with eculizumab (Elizaria) between March 2020 and January 2022...After the second dose, no AEs were reported. The performed study suggests the possible efficacy and demonstrates the safety of Gam-COVID-Vac (Sputnik V) for the prophylaxis of COVID-19 in patients with PNH who experience immunosuppression due to target therapy."

Journal • Complement-mediated Rare Disorders • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Respiratory Diseases

NAP: Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® (clinicaltrials.gov) - P=N/A | N=44 | Completed | Sponsor: AO GENERIUM | Active, not recruiting ➔ Completed

Trial completion • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

NAP: Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® (clinicaltrials.gov) - P=N/A | N=44 | Active, not recruiting | Sponsor: AO GENERIUM | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Apr 2023

Enrollment closed • Trial completion date • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Analytical and functional similarity of biosimilar Elizaria® with eculizumab reference product. (PubMed, J Pharm Biomed Anal) - "Elizaria® Drug Product (DP), developed by IBC Generium, Russia, is the world's first registered biosimilar of eculizumab (Soliris®, Alexion Pharmaceuticals). A multitude of analyses revealed that amino acid sequence is identical, the higher order structures, post-translational modifications, purity, and product variants are highly similar between Elizaria® DP and Eculizumab RP, except for minor differences in the relative abundance of the charge variants and glycan moieties considered not clinically significant. The results demonstrate that Elizaria® is highly analytically similar to Eculizumab RP in terms of physicochemical properties and biological activities."

Journal • Atypical Hemolytic Uremic Syndrome • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Observational Study of Elizaria® in aHUS Patients (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: AO GENERIUM | Recruiting ➔ Completed

Trial completion • Atypical Hemolytic Uremic Syndrome • Complement-mediated Rare Disorders • Nephrology

Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab. (PubMed, Ann Hematol) - P3 | "The aim of this randomized multicenter noninferiority study was to evaluate the efficacy and safety of the Biosimilar (Elizaria) in comparison with the Originator (Soliris) in patients with PNH. The data obtained confirm that the Biosimilar is not inferior to the Originator in terms of the main efficacy parameter, and is also comparable with it in terms of safety and additional efficacy parameters. Clinicaltrials.gov identifier: NCT04463056."

Clinical • Head-to-Head • Journal • P3 data • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Observational Study of Elizaria® in aHUS Patients (clinicaltrials.gov) - P; N=50; Recruiting; Sponsor: AO GENERIUM

Clinical • New trial • Atypical Hemolytic Uremic Syndrome • Complement-mediated Rare Disorders • Nephrology

Results of phase Ib open multicenter clinical trial of the safety, pharmacokinetics and pharmacodynamics of first biosimilar of eculizumab in untreated patients with paroxysmal nocturnal hemoglobinuria during induction of therapy (PubMed, Ter Arkh) - "The study evaluated the pharmacokinetic and pharmacodynamic properties of the drug Elizaria in the regimen of induction therapy in previously untreated patients with PNH, confirming its efficacy. The study demonstrated the safety and low immunogenicity of the study drug."

Clinical • Journal • P1 data • PK/PD data • Allergy • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

NAP: Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® (clinicaltrials.gov) - P; N=50; Recruiting; Sponsor: AO GENERIUM

Clinical • New trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH (clinicaltrials.gov) - P3; N=32; Completed; Sponsor: AO GENERIUM

Clinical • New P3 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Phase III Clinical Trial of Elizaria® and Soliris® in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria: Results of Comparative Analysis of Efficacy, Safety, and Pharmacological Data (ASH 2019) - "Thus, the results of the clinical trial confirm that proposed biosimilar Elizaria® is comparable to the reference product Soliris® in term of efficacy, safety, immunogenicity and PK/PD parameters in the treatment of paroxysmal nocturnal hemoglobinuria."

Clinical • P3 data