Skip to content Skip to footer

Key Biosimilars Events of June 2026 

Shots:  June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC),  and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology,  ophthalmology,  oncology, osteoporosis, and reproductive medicine.  Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.  Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.  Celltrion Seeks…

Read more

Chime Biologics & Daewoong Partner to Develop and Commercialize of Dupilumab (Biosimilar, Dupixent) in Global Markets 

Shots:  Chime Biologics and Daewoong Pharmaceutical signed a strategic partnership to develop and manufacture a biosimilar version of Dupixent  Chime Biologics will support Daewoong's global biosimilar ambitions with its end-to-end development expertise, AI platform, and China's bioprocess supply chain ecosystem  Dupilumab (Dupixent) is a mAb that blocks IL-4 and IL-13 signaling to treat Type 2 inflammation  Ref: Chime Biologics |   Image: Chime Biologics and Daewoong Pharmaceutical | Press Release Related…

Read more