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# FDA Oks Amgen’s Bkemv as Soliris Biosimilar
- URL: https://www.fdaweb.com/fda-oks-amgens-bkemv-as-soliris-biosimilar/
- Published: 2024-05-29T12:00:00.000Z
- Updated: 2026-09-14T14:32:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157074

FDA has approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Alexion’s Soliris (eculizumab) to treat specific rare diseases. An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-two-rare-diseases?utm%5Fmedium=email&utm%5Fsource=govdelivery) says Bkemv is approved for these Soliris indications:

- treating patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis; and
- treating patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy.

Bkemv is described as a monoclonal antibody that binds to the complement C5 protein and inhibits activation of the complement system, a part of the body’s immune system. It has a Boxed Warning for increased risk of serious and life-threatening meningococcal infections caused by *Neisseria meningitidis*.

Bkemv is available only through the Bkemv Risk Evaluation and Mitigation Strategy restricted program, FDA says.