Russian approval for non-originator eculizumab

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Russian approval for non-originator eculizumab

Biosimilares/Novedades | Posted 24/05/2019 0 Post your comment

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 9 April 2019 that the Russian Ministry of Health had approved their eculizumab non-originator biological drug, Elizaria. The drug is a non-originator biological of Soliris (eculizumab), which is made by Alexion Pharmaceuticals.

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 uremic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy.

Elizaria is generated using the SUREtechnology Platform developed by Selexis, and is the fifth biological product to be marketed using this technology. According to Igor Fisch, President of Selexis, this validates the company’s ‘ongoing scientific innovation’ and its commitment to helping their ‘partners address complicated and intractable diseases by developing complex protein therapeutics faster, safer and more cost efficiently’.

No information was given by the companies as to what data the approval was based on. It was also not clear if the design of the clinical trials was developed in accordance with European Medicine Agency or US Food and Drug Administration guidelines.

Soliris had worldwide net sales of US$3.6 billion in 2018 [1]. Generium claims that it ‘is the first company in the world to develop and market a biosimilar of eculizumab’. The composition of matter patent on Soliris will expire in the US on 16 March 2021 (with other composition, use and formulation patents expiring in 2027). European patents will expire on 1 May 2020 [2].

Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in Russia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-eculizumab
2. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007

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Source: Alexion Pharmaceuticals, Generium, Selexis