Last update 20 Mar 2025

Etanercept biosimilar(Lupin Ltd)

Overview

Basic Info

Drug Type
Biosimilar, Fusion protein
Synonyms
Etanercept Biosimilar (Lupin Ltd), Nepexto, エタネルセプト(遺伝子組換え)(株式会社陽進堂)
+ [4]
Action
inhibitors
Mechanism
LTα inhibitors(Tumor necrosis factor β inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ankylosing Spondylitis
Liechtenstein
20 May 2020
Ankylosing Spondylitis
European Union
20 May 2020
Ankylosing Spondylitis
Iceland
20 May 2020
Ankylosing Spondylitis
Norway
20 May 2020
Arthritis, Psoriatic
European Union
20 May 2020
Arthritis, Psoriatic
Liechtenstein
20 May 2020
Arthritis, Psoriatic
Norway
20 May 2020
Arthritis, Psoriatic
Iceland
20 May 2020
Plaque psoriasis
Norway
20 May 2020
Plaque psoriasis
Iceland
20 May 2020
Plaque psoriasis
Liechtenstein
20 May 2020
Plaque psoriasis
European Union
20 May 2020
Polyarthritis
Liechtenstein
20 May 2020
Polyarthritis
European Union
20 May 2020
Polyarthritis
Iceland
20 May 2020
Polyarthritis
Norway
20 May 2020
Juvenile Idiopathic Arthritis
Japan
26 Mar 2019
Juvenile Idiopathic Arthritis
Japan
26 Mar 2019
Rheumatoid Arthritis
Japan
26 Mar 2019
Rheumatoid Arthritis
Japan
26 Mar 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
osrbuwyvwz(dzmgzpsusl) = paweyoomlu gcpxdjkfiu (onccvzsoua )
Positive
02 Jun 2021
Reference Product (RP)
osrbuwyvwz(dzmgzpsusl) = fkcblfqqzq gcpxdjkfiu (onccvzsoua )
Not Applicable
-
201
(mztxtwgvmf) = qonbolmhga lgehfsrtaj (zkkkqkiodv )
-
02 Jun 2021
Phase 3
528
(iumvmebach) = vzbnmbcvpg txagydfycd (ksugdtfhxb )
Positive
12 Jun 2019
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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.
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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