On 1 September 2025, Medical Dialogues reported that Lupin received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase 1 study of its certolizumab pegol biosimilar in 200mg PFS presentation, referencing UCB’s Cimzia®.
In July 2025, Lupin Limited and Zentiva Group announced that they entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar. Under the agreement, Lupin is responsible for development, manufacturing and supply, with split responsibility for commercialisation: Lupin in the US and Canada, with Zentiva in ROW, predominantly Europe and CIS markets.
Alvotech also has a certolizumab pegol biosimilar in development, AVT10, which it acquired from Xbrane in June 2025. In early July 2025, Alvotech and Advanz Pharma entered a European supply and commercialisation agreement for AVT10.