On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab). The biosimilar, Limiris™, has been approved as a lyophilised powder for subcutaneous injection and is indicated for the treatment of Still’s disease, systemic juvenile idiopathic arthritis, autoinflammatory diseases, and gouty arthritis.
Generium offers a number of biosimilar products in Russia including Elizaria®, biosimilar to Alexion’s Soliris® (eculizumab) (approved April 2019) and Genolar®, biosimilar to Genentech’s Xolair® (omalizumab) (approved February 2022).
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 in Europe.