FDA approved the original biologics license application for ABRILADA on November 15, 2019, sponsored by PFIZER INC. FDA has approved 3 efficacy supplements on the application since, the most recent on October 4, 2023.
- Application
- BLA761118
- Sponsor
- PFIZER INC
- Original approval
- Review
- standard review
- Submission class
- Type 2 - New Active Ingredient
- Active ingredient
- adalimumab-afzb
Browse every approval whose brand starts with A, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| adalimumab-afzb 10MG/0.2ML | INJECTABLE | INJECTION | Prescription |
| adalimumab-afzb 40MG/0.8ML | INJECTABLE | INJECTION | Prescription |
| adalimumab-afzb 20MG/0.4ML | INJECTABLE | INJECTION | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-6 | standard | |
| S-9 | standard | |
| S-7 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Bioequivalence 1 · Type 2 - New Active Ingredient 1 · Labeling 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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