trastuzumab
Marketed as ONTRUZANT, HERCEPTIN.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA761100 | ONTRUZANT | 2019-01-18 | SAMSUNG BIOEPIS CO LTD |
| BLA103792 | HERCEPTIN | 1998-09-25 | GENENTECH |
Manufacturers
SAMSUNG BIOEPIS CO LTD, GENENTECH
Common denial patterns
- Plan-mandated biosimilar switch mid-treatment
- HER2 IHC 2+ with FISH equivocal — plan demands IHC 3+
- Adjuvant duration beyond 1 year
- Site-of-care reduction
Specific notes
Brand: Herceptin. Reference biologic for HER2-positive breast and gastric cancer. Biosimilars: Kanjinti, Trazimera, Ogivri, Ontruzant, Herzuma. Also a component of Enhertu (trastuzumab deruxtecan, separate molecule) and Kadcyla.
Genentech Patient Foundation: https://www.gene.com/patients/patient-foundation
Frequently asked questions
Why does insurance commonly deny trastuzumab?
Plan-mandated biosimilar switch mid-treatment; HER2 IHC 2+ with FISH equivocal — plan demands IHC 3+; Adjuvant duration beyond 1 year; Site-of-care reduction.
When was trastuzumab FDA approved?
Earliest FDA approval on record: 1998-09-25.
What brand names are sold as trastuzumab?
ONTRUZANT, HERCEPTIN.
Is there a patient assistance program for trastuzumab?
Yes — Genentech Patient Foundation at https://www.gene.com/patients/patient-foundation.
What's specific to trastuzumab?
Brand: Herceptin. Reference biologic for HER2-positive breast and gastric cancer. Biosimilars: Kanjinti, Trazimera, Ogivri, Ontruzant, Herzuma. Also a component of Enhertu (trastuzumab deruxtecan, separate molecule) and Kadcyla.
Related
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