recombinant human erythropoietin biosimilar / Hindustan Antibiotics - LARVOL DELTA

Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=43 | Completed | Sponsor: Bio Sidus SA | Active, not recruiting ➔ Completed | N=120 ➔ 43

Enrollment change • Trial completion • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Pharmacokinetic and pharmacodynamic study of 3 products of epoetin alfa as single subcutaneous dose in healthy volunteers. (PubMed, Fundam Clin Pharmacol) - "The comparison between Hemax® PFS and Eprex® resulted in similar 90%CI for C , AUC and AUC ratios, all of them within the 80-125% interval, with a power above 95% for each ratio. These findings suggest biosimilar patterns for absorption velocity (with Tmax close to 15 h), absorption extent and elimination (with an elimination half-life close to 25-30 h for each formulation)."

Journal • PK/PD data

Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease (clinicaltrials.gov) - P3; N=120; Active, not recruiting; Sponsor: Bio Sidus SA; Recruiting ➔ Active, not recruiting; Trial completion date: Jan 2021 ➔ Jan 2022; Trial primary completion date: Sep 2020 ➔ Jul 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Evaluation of erythropoietin biosimilars Epotin™, Hemax® and Jimaixin™ by electrophoretic methods used for doping control analysis and specific N-glycan analysis revealed structural differences from original epoetin alfa drug Eprex®. (PubMed, J Pharm Biomed Anal) - "Jimaixin™ and Epotin™ presented also a lower amount of fully sialylated forms. HILIC method also showed that O-acetylation level of sialic acid residues might vary from one rEPO to the other."

Journal • EPO

[VIRTUAL] ANALYSIS OF THE USE OF COMMERCIAL NAMES IN THE MEDICAL REQUIREMENTS OF A UNIVERSITY HOSPITAL COMPARED TO THESE PERFORMED IN THE ONCOLOGY SERVICE (HEMO 2020) - "The following medications were more prescribed: Clexane® (179), Tramal® (123), Hemax® (48) and AAS® (25). Legislation guidelines and recommendations provided, both in national and international literature, are not being complied with, except in the Oncology Service, which constitutes a sanitary infraction at the University Hospital itself. This result points, therefore, a non-conformity when analyzed according to the specific legislation."

Clinical • Hematological Disorders • Oncology

Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Bio Sidus SA

Clinical • New P3 trial