Abcertin (imiglucerase) / ISU Abxis - LARVOL DELTA

A Randomized, Double-Blind, 2-Treatment, 2-Period, Crossover Phase 1 Study to Compare the Pharmacokinetics, Safety and Tolerability of 60 IU/Kg of Abcertin and Cerezyme in Healthy Volunteers Following a Single Intravenous Administration. (PubMed, Mol Genet Genomic Med) - "Abcertin demonstrated pharmacokinetic equivalence to Cerezyme, with a comparable safety, immunogenicity, and tolerability profile. These findings support its potential as an affordable biosimilar for GD treatment."

Clinical • Journal • P1 data • PK/PD data • Dermatology • Gaucher Disease • Genetic Disorders • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Pain • Urticaria

A RANDOMIZED, DOUBLE-BLIND, 2-TREATMENT, 2-PERIOD, CROSSOVER PHASE 1 STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ABCERTIN AND CEREZYME® (SSIEM 2024) - "Similar pharmacokinetic, safety and immunogenicity profiles were observed between Abcertin and Cerezyme, suggesting good tolerability of both imiglucerases in healthy subjects."

Clinical • P1 data • PK/PD data • Dermatology • Gaucher Disease • Genetic Disorders • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Pain • Urticaria

Use of Identical INN "Imiglucerase" for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database. (PubMed, Drug Saf) - "This analysis demonstrates two potential consequences of identical INN use between Cerezyme and Asbroder: (1) an aggregate safety profile for Cerezyme that includes other products using the identical INN leading to inaccurate pharmacovigilance data and (2) healthcare providers switching, substituting, or potentially assuming interchangeability between the products. Identical INN use without the brand name differentiator may compromise pharmacovigilance data, potentially masking differences in safety profiles between products."

Adverse events • Clinical • Journal • Gaucher Disease • Genetic Disorders • Metabolic Disorders

A Phase I Study to Compare the PK, Safety and Tolerability of Abcertin, and EU-sourced Cerezyme® in Healthy Volunteers (clinicaltrials.gov) - P1; N=42; Completed; Sponsor: ISU Abxis Co., Ltd.

Clinical • New P1 trial • Gaucher Disease • Genetic Disorders • Metabolic Disorders