Epysqli — licensed biologic

Overview

Source: Purple Book

Proprietary name

Epysqli

Proper name

eculizumab-aagh

Licence type

351(k) Interchangeable

BLA number

761340

Applicant

Samsung Bioepis Co., Ltd.

Center

CDER

Presentations

1

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 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
300MG/30ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	July 19, 2024

Reference product

Source: Purple Book

This product is licensed with reference to Soliris (eculizumab).

View reference product Search the small-molecule catalogue

Sources for this page

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