Hervelous

Application withdrawnHuman

Biosimilar

Details

EMA number	EMEA/H/C/005880
ATC code	L01XC03
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)

MeSH: Stomach Neoplasms;Breast Neoplasms

Group: Antineoplastic agents

Active substances

trastuzumab

Marketing Authorisation Holder

Prestige Biopharma Belgium

MAH

🇺🇸 Also approved in the US (FDA)

ONTRUZANT — SAMSUNG BIOEPIS CO LTD, approved 2026-04-15 (BLA761100).

Most reported adverse events (US / FAERS)

64,031 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

diarrhoea

7,667

off label use

6,105

nausea

5,937

fatigue

5,423

alopecia

🇺🇸 Also approved in the US (FDA)

ONTRUZANT — SAMSUNG BIOEPIS CO LTD, approved 2026-04-15 (BLA761100).

Most reported adverse events (US / FAERS)

64,031 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

diarrhoea

7,667

off label use

6,105

nausea

5,937

fatigue

5,423

alopecia

5,389

death

5,187

disease progression

4,774

vomiting

3,695

dyspnoea

3,305

myelosuppression

3,259

pyrexia

3,060

asthenia

2,848

neutropenia

2,504

pain

2,467

neuropathy peripheral

2,411