Wyost — licensed biologic

Overview

Source: Purple Book

Proprietary name

Wyost

Proper name

denosumab-bbdz

Licence type

351(k) Interchangeable

BLA number

761362

Applicant

Sandoz Inc.

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
120MG/1.7ML (70MG/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	March 5, 2024

Reference product

Source: Purple Book

This product is licensed with reference to Xgeva (denosumab).

View reference product Search the small-molecule catalogue

Sources for this page

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