Generium launches omalizumab (Xolair) non-originator in Russia

Biosimilares/Novedades | Posted 11/03/2022 post-comment0 Post your comment

Moscow’s Generium has launched a non-originator biological of omalizumab (Xolair) on the Russian market, the third of Generium’s products using Selexis’ SUREtechnology Platform to reach the market.

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Omalizumab is a monoclonal antibody used to treat asthma, as well as nasal polyps and chronic idiopathic urticaria (itchy rash). It is sold under the brand name Xolair by Genentech/Novartis.

On 9 February 2022, Russian firm Generium announced the launch of a non-originator biological of omalizumab in Russia, under the brand name Genolar. Genolar is a recombinant humanized IgG1k monoclonal antibody that binds to free human immunoglobulin E (IgE).

The product is available in Russia for the treatment of persistent atopic bronchial asthma (the most common form of asthma) in patients aged 6 and older and resistant chronic idiopathic urticaria in patients aged 12 and older.

Genolar is manufactured in collaboration with Swiss firm Selexis, whose SUREtechnology Platform can be used in the production of therapeutic recombinant proteins and monoclonal antibodies. The technology uses a Chinese hamster ovary (CHO) cell line to increase the stable expression of recombinant proteins.

Genolar is the third non-originator biological made using Selexis’ platform to reach the market under commercial license agreements between Generium and Selexis, following eculizumab [1] and dornase alfa [2]. It is also the ninth biological product made using the Selexis platform to be marketed overall.

Selexis’ Chief Business Officer Dr Roland Hecht said: ‘Our collaboration with Generium is a proof of Selexis’ ability to provide to our clients stable and scalable high-titer cell lines for cost effective clinical and commercial production, and we’re thrilled to play a continued role in the success of Generium’s programs’.

Generium CEO Daniil Talyanskiy added: ‘Our longstanding partnership with Selexis has brought forth multiple therapeutic solutions in the fields of hematology and pulmonology for the development of CHO-generated biosimilar products. Selexis’ reputation as a leading cell line developer is unparalleled and vital to our success bringing high-quality biologics to the Russian healthcare system’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Russian approval for non-originator eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 11]. Available from: www.gabionline.net/biosimilars/news/Russian-approval-for-non-originator-eculizumab
2. GaBI Online - Generics and Biosimilars Initiative. Russian approval for non-originator dornase alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 11]. Available from: www.gabionline.net/biosimilars/news/Russian-approval-for-non-originator-dornase-alfa

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Source: Selexis

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