Bekemv (eculizumab)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- eculizumab
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Hemoglobinuria, Paroxysmal
- CHMP opinion
- Thu 23 Feb 2023
- EU approval
- Wed 19 Apr 2023
- Designations
- Biosimilar
- Application
- EMEA/H/C/005652
- ATC
- L04AJ01
- Official record
- www.ema.europa.eu
Indication
Bekemv 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 (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Epysqli Authorised · Samsung Bioepis NL 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.