Russian approval for non-originator dornase alfa

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Russian approval for non-originator dornase alfa

Biosimilars/News | Posted 18/10/2019 0 Post your comment

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 17 September 2019 that the Russian Ministry of Health had approved their dornase alfa non-originator biological drug, Tigerase. The drug is a non-originator biological of Roche’s Pulmozyme (dornase alfa).

Dornase alfa is a highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves deoxyribonucleic acid (DNA). Dornase alfa hydrolyzes the DNA present in the sputum/mucus of cystic fibrosis patients and reduces viscosity in the lungs, promoting improved clearance of secretions. It is therefore indicated to improve lung function in patients with cystic fibrosis.

Tigerase is generated using the SUREtechnology Platform developed by Selexis, and is the sixth biological product to be marketed using this technology. According to Igor Fisch, President of Selexis, ‘this biologic’s market approval in Russia represents another major milestone for Selexis’. He adds that Selexis is ‘pleased to recognize the work of Generium in delivering the fifth and sixth approvals using our SUREtechnology Platform’.

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.

Pulmozyme had worldwide sales of CHF 739 million (Euros 670 million) in 2018. Generium claims that it ‘is the first company in the world to develop and market a biosimilar of dornase alfa’. The patents on Pulmozyme expired in the US in 2015 and in Europe in 2019 [1].

The pair also had an eculizumab non-originator biological drug, Elizaria, approved in Russia in April 2019 [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. 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
2. GaBI Online - Generics and Biosimilars Initiative. Russian approval for non-originator eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 18]. Available from: www.gabionline.net/Biosimilars/News/Russian-approval-for-non-originator-eculizumab

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Source: Selexis