Prestige Biopharma — Tuznue EMA EPAR public assessment report (EMEA/H/C/006252, 2024)
Prestige Biopharma · 2024 · EMA EPAR public assessment report
Report summary
The EMA's assessment of Prestige Biopharma's Tuznue (trastuzumab) biosimilar confirms its high similarity to the reference product, Herceptin. Extensive analytical, non-clinical, and clinical comparability studies, including the TROIKA Phase III trial, demonstrated comparable quality, molecular attributes, functional activities, pharmacokinetics, and efficacy (total pathological complete response in early breast cancer). Safety profiles were also similar. Based on these findings, Tuznue is recommended for marketing authorization for all Herceptin indications: HER2-positive metastatic and early breast cancer, and metastatic gastric cancer.
Key findings — cited to the page
| Application submission date | 31 July 2023 | Tuznue · p.7 |
| Procedure number | EMEA/H/C/006252/0000 | Tuznue · p.1 |
| Legal basis for application | Article 10(4) of Directive 2001/83/EC | · p.7 |
| Reference product marketing authorisation date | 28-08-2000 | Herceptin · Union · p.8 |
| Reference product marketing authorisation number | EU/1/00/145/001 | Herceptin · Union · p.8 |
| CHMP positive opinion date | 25 July 2024 | Tuznue · p.10 |
| Molecular weight of trastuzumab | 148 kDa | · p.12 |
| Number of amino acids in light chain | 214 | · p.12 |
| Approval recommendation | Favourable benefit-risk balance | Tuznue · p.128 |
| Number of amino acids in heavy chain | 449 | · p.12 |
| Number of inter-chain disulfide bonds | 4 | · p.12 |
| Number of intra-chain disulfide bonds | 12 | · p.12 |
Source: Prestige Biopharma ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →