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Cyltezo
adalimumab-adbm
351(k) Interchangeable Pharmacy-substitutable
Overview
Source: Purple BookProprietary name
Cyltezo
Proper name
adalimumab-adbm
Licence type
351(k) Interchangeable
BLA number
761058
Applicant
Boehringer Ingelheim Pharmaceuticals, Inc.
Center
CDER
Presentations
6
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 | March 18, 2022 |
| 20MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | July 13, 2018 |
| 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 30, 2024 |
| 40MG/0.4ML | Injection | Subcutaneous | Autoinjector | Rx | April 30, 2024 |
| 40MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | August 25, 2017 |
| 40MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | May 18, 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 |