Isu Abxis has developed a biosimilar of Soliris (eculizumab), which is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disease which causes the destruction of red blood cells.

The treatment improves quality of life for people with PNH and reduces the need for blood transfusions and can also be used to treat atypical hemolytic uremic syndrome (aHUS) and neuromyelitis optica (NMO).

Under an agreement signed with the Russian company Pharmasyntez, Isu Abxis will transfer the technology for its biosimilar (ISU305) in return for a down payment, milestone payments, and royalties. A further Soliris non-originator, made by Alexion Pharmaceuticals, was approved by the Russian Ministry of Health in April 2019 [1].

Phase I clinical trials for ISU305 have been completed by Isu Abxis and Pharmasyntez intends to conduct further phase II and phase III trials. Commenting on the deal, which is the first technology transfer for Isu Abxis, an official said: ‘We plan to establish a close partnership with Pharmasyntez on the occurrence of this contract to advance into Russia and CIS regions in the future’.

In related news, Icelandic company Alvotech and Japanese company Fuji Pharma have agreed to extend their strategic partnership to commercialize four biosimilar medicines in Japan, which was signed in 2018 [2].

Fuji Pharma will exclusively commercialize the medicines in Japan, with discussions ongoing regarding additional biosimilar candidates. The extended agreement gives Fuji Pharma the option to enter into new therapeutic areas.

Atsuya Mitsuhashi, Fuji Pharma’s General Manager, commented: ‘… With inclusion of four new biosimilar medicines to our existing partnership, Fuji Pharma now has an industry leading biosimilar pipeline in the world’s 2nd largest market for the biologic medicines ...’.

Anil Okay, Chief Commercial Officer for Alvotech, added: ‘… The binding term sheet takes Alvotech one step closer to gaining further access to Japan’s fast‐growing biosimilars market, forecasted to grow as much as 35% CAGR over the next years. We will also continue our discussions with Fuji Pharma for additional products from our biosimilar portfolio’.

Related articles
Alexion delays Soliris biosimilar until 2025

Phase III trial started in China for eculizumab copy biological

Fuji Pharma acquires stake in Alvotech

References
1. GaBI Online - Generics and Biosimilars Initiative. Russian approval for non-originator eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/News/Russian-approval-for-non-originator-eculizumab 
2. GaBI Online - Generics and Biosimilars Initiative. Alvotech makes deal with Fuji Pharma for biosimilars in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Pharma-News/Alvotech-makes-deal-with-Fuji-Pharma-for-biosimilars-in-Japan 

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