Abrilada — licensed biologic

Overview

Source: Purple Book

Proprietary name

Abrilada

Proper name

adalimumab-afzb

Licence type

351(k) Interchangeable

BLA number

761118

Applicant

Pfizer Inc.

Center

CDER

Presentations

5

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/0.2ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	November 15, 2019
20MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	November 15, 2019
40MG/0.8ML	Injection	Subcutaneous	Autoinjector	Rx	November 15, 2019
40MG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	November 15, 2019
40MG/0.8ML	Injection	Subcutaneous	Single-Dose Vial	Rx	November 15, 2019

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