Ogivri

Application withdrawn

Human

Biosimilar

Details

EMA number	EMEA/H/C/004346
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

Active substances

trastuzumab

Marketing Authorisation Holder

MAH

Mylan S.A.S.

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

Timeline

Filter by authority:

Ogivri authorised

12 Dec 2018

authorisedregulatory

Status changed: Authorised → Application withdrawn

28 Nov 2017

status_changedregulatory

🇺🇸 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