On 1 October 2026, Samsung Bioepis and Teva Pharmaceuticals announced a global collaboration and licence agreement to expand their existing partnership for up to six additional biosimilars. The products covered by the agreement include SB44, biosimilar to Novartis’ Ilaris® (canakinumab), and SB41, biosimilar to AstraZeneca’s Fasenra® (benralizumab), plus four other undisclosed early-stage biosimilars.
Under the agreement, Samsung Bioepis is responsible for development, regulatory approval and manufacture, while Teva is responsible for commercialisation of the biosimilars in global markets including the US, Canada and Europe, with an option to expand the partnership to other territories.
Teva and Samsung Bioepis first entered into a strategic partnership in January 2025 for the US-commercialisation of Samsung Bioepis’ Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. In July 2026, that agreement was expanded to include the commercialisation of Samsung Bioepis’ Opuviz® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, in Canada.
No canakinumab biosimilars are reported to have been approved in major markets. However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar in Europe. Generium’s Limiris™ (canakinumab) was approved in Russia in September 2025, while it was reported in June 2026 that Belarusian company BioImmunity LLC obtained registration in Belarus of its canakinumab biosimilar and was seeking approval for the drug in Russia.
Benralizumab biosimilars are still in early development. Enzene has a benralizumab biosimilar within its development pipeline.