Last update 20 Mar 2025

Canakinumab Biosimilar (Generium)

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Target
IL-1β
Action
inhibitors
Mechanism
IL-1β inhibitors(Interleukin-1 beta inhibitors)
Therapeutic Areas
Immune System DiseasesSkin and Musculoskeletal DiseasesOther Diseases
Active Indication
Still's Disease, Adult-OnsetSystemic onset juvenile chronic arthritis
Inactive Indication-
Originator Organization
Generium ZAO
Active Organization
Generium ZAO
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

Related

2
Clinical Trials associated with Canakinumab Biosimilar (Generium)
NCT06497491
/ RecruitingPhase 3
A Single-blind Randomized Study of the Efficacy and Safety of the GNR-086 (canakinumab Proposed Biosimilar) in Comparison with the Ilaris®, Conducted in Parallel Groups of Patients with Adult-onset Still's Disease
NCT06481189
/ CompletedPhase 1
A Single-blind Randomized Parallel-group Comparative Study of the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of GNR-086 and Ilaris® After a Single Subcutaneous Administration to Healthy Volunteers at a Dose of 150 mg
100 Clinical Results associated with Canakinumab Biosimilar (Generium)
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100 Translational Medicine associated with Canakinumab Biosimilar (Generium)
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100 Patents (Medical) associated with Canakinumab Biosimilar (Generium)
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100 Deals associated with Canakinumab Biosimilar (Generium)
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Still's Disease, Adult-OnsetPhase 3
Russia
Generium ZAO
12 Dec 2023
Systemic onset juvenile chronic arthritisPhase 3
Russia
Generium ZAO
29 Jun 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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