Erelzi — licensed biologic

Overview

Source: Purple Book

Proprietary name

Erelzi

Proper name

etanercept-szzs

Licence type

351(k) Biosimilar

BLA number

761042

Applicant

Sandoz Inc.

Center

CDER

Presentations

3

First licensure

—

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 is licensed as a biosimilar but is not designated interchangeable, so substitution requires 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	For Injection	Subcutaneous	Multi-Dose Vial	Disc	November 10, 2022
25MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	August 30, 2016
50MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	August 30, 2016

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