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Jobevne

bevacizumab-nwgd

351(k) Biosimilar

Overview

Source: Purple Book
Proprietary name
Jobevne
Proper name
bevacizumab-nwgd
Licence type
351(k) Biosimilar
BLA number
761175
Applicant
Biocon Biologics Inc.
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
100MG/4ML (25MG/ML) Injection Intravenous Single-Dose Vial Rx April 9, 2025
400MG/16ML (25MG/ML) Injection Intravenous Single-Dose Vial Rx April 9, 2025

Reference product

Source: Purple Book

This product is licensed with reference to Avastin (bevacizumab).

Sources for this page

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