Epysqli (eculizumab)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- eculizumab
- Company
- Samsung Bioepis NL B.V.
- Status
- Authorised
- Therapeutic area
- Hemoglobinuria, Paroxysmal
- CHMP opinion
- Thu 30 Mar 2023
- EU approval
- Fri 26 May 2023
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006036
- ATC
- L04AJ01
- Official record
- www.ema.europa.eu
Indication
Epysqli is indicated in adults and children for the treatment of: Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. Atypical haemolytic uremic syndrome (aHUS).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Bekemv Authorised · Amgen Europe B.V.
- 🇪🇺 Soliris Authorised · Alexion Europe SAS
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.