Delving into the Latest Updates on Omalizumab biosimilar (Generium Pharmaceuticals) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Omalizumab biosimilar, 奥马佐单抗生物类似药(Generium Pharmaceuticals), GNR-044

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Target

IgE

Mechanism

IgE inhibitors(Immunoglobulin E inhibitors)

Therapeutic Areas

Immune System DiseasesRespiratory DiseasesSkin and Musculoskeletal Diseases

Active Indication

AsthmaChronic UrticariaAllergic asthma

Inactive Indication

Persistent asthma

Originator Organization

Generium ZAO

Active Organization

Selexis SAGenerium ZAO

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

RU (09 Feb 2022),

AsthmaChronic Urticaria

Regulation-

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Gene Sequence

Sequence Code 81670L

The sequence is quoted from: *****

Sequence Code 143601H

The sequence is quoted from: *****

This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in healthy volunteers

Start Date15 Jan 2023

Sponsor / Collaborator

Generium ZAO

NCT04607629 / CompletedPhase 3

A Comparative Study of Efficacy and Safety of Genolar® and Xolar® in Treating Patients With Moderate to Severe Persistent Atopic Bronchial Asthma Inadequately Controlled With Stage 4 GINA (2017) Treatment

This is a randomized, double-blind, comparative, parallel-group study of the efficacy and safety of Genolar® and Xolair® in the treatment of persistent atopic bronchial asthma of moderate and severe course, whose symptoms are insufficiently controlled by the 4-step treatment GINA (2017)

Start Date20 Jun 2018

Sponsor / Collaborator

Generium ZAO

NCT04601389 / CompletedPhase 1

An Open-label, Randomized, in Parallel Groups Comparative Study of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Omalizumab (JSC "GENERIUM", Russia) and Xolair® ("Novartis Pharma AG", Switzerland) After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg

An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland) after single subcutaneous administration in healthy volunteers at 150 mg

Start Date18 Apr 2017

Sponsor / Collaborator

Generium ZAO

100 Clinical Results associated with Omalizumab biosimilar (Generium Pharmaceuticals)

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100 Translational Medicine associated with Omalizumab biosimilar (Generium Pharmaceuticals)

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100 Patents (Medical) associated with Omalizumab biosimilar (Generium Pharmaceuticals)

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100 Deals associated with Omalizumab biosimilar (Generium Pharmaceuticals)

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