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New Single-Dose Vial Approved for a Pfizer Biosimilar
On behalf of Pfizer, it is our pleasure to inform you that on November 30th, 2020, the U.S. Food and Drug Administration (FDA) approved the 150 mg single-dose vial of TRAZIMERA® (trastuzumab-qyyp). TRAZIMERA (trastuzumab-qyyp) is a biosimilar to Herceptin®Ϯ (trastuzumab). As of March 10th, 2021 this new presentation is now available for commercial sale.
Please review the TRAZIMERA Full Prescribing Information, including BOXED WARNINGS, for detailed information.
The product information, including new NDC, is listed in the table below.
TRAZIMERA Product Information
| NEW | EXISTING | |
| Type | Single-dose vial | Multiple-dose vial |
| Strength | 150 mg of TRAZIMERA as a white lyophilized powder in a single-dose vial | 420 mg of TRAZIMERA as a white lyophilized powder in a multiple-dose vial |
|
Package size |
1 vial per carton | 1 vial per carton |
| NDC | 0069-0308-01 | 0069-0305-01 |
| WAC | $1,211.10 | $3391.08 |
| Q-Code | Q5116: Injection, trastuzumab-qyyp, biosimilar (Trazimera, 10 mg) | |
Note: WAC price is a manufacturer’s undiscounted price and is not inclusive of contracts, rebates, or other discounts.
