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Eticovo

etanercept-ykro

351(k) Interchangeable 351(k) Biosimilar Pharmacy-substitutable

Overview

Source: Purple Book

Proprietary name

Eticovo

Proper name

etanercept-ykro

Licence type

351(k) Interchangeable · 351(k) Biosimilar

BLA number

761066

Applicant

Samsung Bioepis Co., Ltd.

Center

CDER

Presentations

First licensure

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351(k) biosimilar pathway. This product was licensed as highly similar to a reference product, with no clinically meaningful differences in safety, purity or potency. It also carries the interchangeable designation, so a pharmacist may substitute it for the reference product without contacting the prescriber.

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
25MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	April 25, 2019
50MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	April 25, 2019
50MG/ML	Injection	Subcutaneous	Autoinjector	Disc	May 3, 2024

Reference product

Source: Purple Book

This product is licensed with reference to Enbrel (etanercept).

View reference product Search the small-molecule catalogue

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity