Hyrimoz — licensed biologic

Overview

Source: Purple Book

Proprietary name

Hyrimoz

Proper name

adalimumab-adaz

Licence type

351(k) Interchangeable

BLA number

761071

Applicant

Sandoz Inc.

Center

CDER

Presentations

10

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
10MG/0.1ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 20, 2023
10MG/0.2ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	March 28, 2022
20MG/0.2ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 20, 2023
20MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 20, 2023
40MG/0.4ML	Injection	Subcutaneous	Autoinjector	Rx	March 20, 2023
40MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 20, 2023
40MG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	October 30, 2018
40MG/0.8ML	Injection	Subcutaneous	Autoinjector	Rx	October 30, 2018
80MG/0.8ML	Injection	Subcutaneous	Autoinjector	Rx	March 20, 2023
80MG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	March 20, 2023

Reference product

Source: Purple Book

This product is licensed with reference to Humira (adalimumab).

View reference product Search the small-molecule catalogue

Sources for this page

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