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BioImmunity Seeks Approval of Biosimilar Canakinumab in Russia

Jun 4, 2026

On 4 June 2026, GxP News reported that Belarusian company, BioImmunity LLC, has obtained registration in Belarus of its biosimilar to Novartis’ Ilaris® (canakinumab) and is seeking approval in Russia.  If registered, this will become the second canakinumab biosimilar approved in Russia after Generium’s Limiris™ (September 2025).

There have not been any reports of canakinumab biosimilars approved elsewhere.  However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar (AVT48) in Europe.