FDA approves first eculizumab biosimilar Bkemv for two rare diseases

Biosimilars/News | Posted 09/07/2024 post-comment0 Post your comment

On 28 May 2024, the US Food and Drug Administration (FDA) approved Amgen's Bkemv (eculizumab-aeeb), the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris approved in the US.

Rare disease V24G08

Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is approved to treat two rare blood disorders (paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) caused when the immune system attacks and damages red blood cells and platelets. In treatment of people with PNH, it improves quality of life but does not appear to affect the risk of death. It is also indicated for the treatment of patients with aHUS – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy [1].

Bkemv is approved for the same indications, see below, as the originator, as an interchangeable biosimilar:

  • the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) to reduce hemolysis; and
  • the treatment of patients with aHUS to inhibit complement-mediated thrombotic microangiopathy. 

This means it can be substituted for the originator at the pharmacy level, without clinician approval.

The approval comes with a black box warning about the risk of serious infections caused by a bacteria called Neisseria meningitidis.

Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy (REMS).

The product has already been approved in Europe in 2023 [2]. AstraZeneca acquired the intravenous injection, Soliris, through a US$39 billion buyout of Alexion Pharmaceuticals in 2020. It can now be marketed in the US following a 2020 settlement between Amgen and AstraZeneca/Alexion that prevented the product from reaching the market until 2025 [3].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 9]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-eculizumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of eculizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 9]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-eculizumab-biosimilar-bekemv
3. GaBI Online - Generics and Biosimilars Initiative. Alexion delays Soliris biosimilar until 2025 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 9]. Available from:

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