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Amjevita
adalimumab-atto
351(k) Interchangeable Pharmacy-substitutable
Overview
Source: Purple BookProprietary name
Amjevita
Proper name
adalimumab-atto
Licence type
351(k) Interchangeable
BLA number
761024
Applicant
Amgen Inc.
Center
CDER
Presentations
9
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| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 6, 2023 |
| 20MG/0.2ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 14, 2023 |
| 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | September 23, 2016 |
| 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 14, 2023 |
| 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | August 14, 2023 |
| 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | September 23, 2016 |
| 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | September 23, 2016 |
| 80MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 14, 2023 |
| 80MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | August 14, 2023 |
Reference product
Source: Purple BookThis product is licensed with reference to Humira (adalimumab).
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |