Ontruzant — licensed biologic

Overview

Source: Purple Book

Proprietary name

Ontruzant

Proper name

trastuzumab-dttb

Licence type

351(k) Biosimilar

BLA number

761100

Applicant

Samsung Bioepis Co., Ltd.

Center

CDER

Presentations

2

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
150MG	For Injection	Intravenous	Single-Dose Vial	Rx	January 18, 2019
420MG	For Injection	Intravenous	Multi-Dose Vial	Rx	March 20, 2020

Reference product

Source: Purple Book

This product is licensed with reference to Herceptin (trastuzumab).

View reference product Search the small-molecule catalogue

Sources for this page

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