EMA recommends approval of eculizumab biosimilar Bekemv

Biosimilars/News | Posted 23/03/2023 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2023 that it had recommended granting of marketing authorization for the eculizumab biosimilar Bekemv.

Eculizumab Blood Brodsky V23C23

Bekemv is a biosimilar candidate developed by Amgen referencing Alexion’s biological product Soliris (eculizumab).

Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxysmal nocturnal haemoglobinuria (PNH), for whom 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 atypical haemolytic uraemic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy [1]. 

The positive opinion from the EMA’s CHMP recommends that Bekemv be used for the treatment of paroxysmal nocturnal haemoglobinuria in adults and children. Paroxysmal nocturnal haemoglobinuria is a life-threatening genetic disease that causes the breakdown of red blood cells resulting in various medical complications. Bekemv is the first biosimilar approved for this active substance. Unlike the reference product, Bekemv is contraindicated in patients with hereditary fructose intolerance and in children below two years of age.

Soliris was approved in the US by the Food and Drug Administration (FDA) in 2007 and posted US$1.87 billion in global sales in 2021 [2]. The patents for Soliris expired in the US on 16 March 2021 and in Europe on 1 May 2020 [3]. If approved, Bekemv would become the first eculizumab biosimilar to be granted European marketing authorization. However, in the US, an agreement was reached between Amgen and Alexion that means the biosimilar product cannot be marketed by Amgen until 2025 [4].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 23]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-eculizumab
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Samsung Bioepis’ Soliris biosimilar[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 23]. Available from: www.gabionline.net/biosimilars/research/positive-phase-iii-results-for-samsung-bioepis-soliris-biosimilar
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
4. GaBI Online - Generics and Biosimilars Initiative. Alexion delays Soliris biosimilar until 2025.  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 23]. Available from: www.gabionline.net/policies-legislation/Alexion-delays-Soliris-biosimilar-until-2025

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Source: EMA

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