Tuznue(trastuzumab)

Oncology· 119 cited findings· 1 source document

Company: Prestige Biopharma

What the regulatory reviews say

Tuznue (trastuzumab), also referred to as HD201, is a biosimilar product. The application for its marketing authorization was submitted on 31 July 2023, under Article 10(4) of Directive 2001/83/EC, with a favorable benefit-risk balance recommended by the CHMP on 25 July 2024. The reference product's marketing authorization date was 28-08-2000.

In a Phase III study (TROIKA), the primary objective was to show equivalence in terms of total pathological complete response (tpCR). The ratio of geometric mean of AUC0-inf for HD201 versus EU-Herceptin was 102.45% (90% CI: [95.95%; 109.40%]). The ratio of tpCR between groups in the PPS population was 1.01 (95% CI: [0.832; 1.225]). The mean ratio (90% CI) of Ctrough (HD201 vs. EU-Herceptin) before Cycle 5 in mFAS was 99.3% (90% CI: [91.2%; 108.2%]).

Safety data from the neoadjuvant/adjuvant treatment period showed 7 deaths in the HD201 group compared to 0 deaths in the Herceptin group. During neoadjuvant treatment specifically, there were 3 deaths in the HD201 group and 0 in the EU-Herceptin group.

Key figures — cited to the source page

Ratio of geometric mean of AUC0-inf (HD201 vs. EU-Herceptin)	102.45 %	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.38
90% CI for ratio of geometric mean of AUC0-inf (HD201 vs. EU-Herceptin)	[95.95%; 109.40%]	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.38
Ratio of tpCR between groups in PPS	1.01	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.55
95% CI for ratio of tpCR between groups in PPS	[0.832; 1.225]	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.55
deaths during neoadjuvant/adjuvant treatment (HD201)	7	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.70
deaths during neoadjuvant/adjuvant treatment (Herceptin)	0	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.70
CHMP positive opinion date	25 July 2024	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.10
Approval recommendation	Favourable benefit-risk balance	Prestige Biopharma — Tuznue EMA EPAR public assessment repor, p.128

Source documents

Prestige Biopharma — Tuznue EMA EPAR public assessment report (EMEA/H/C/006252, 2024) (2024)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.