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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…

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GlycoNex Reports the P-III Trial Data on SPD8 (Biosimilar, Denosumab)

Shots: GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), a biosimilar version of denosumab co-developed with Mitsubishi Gas Chemical, vs Prolia in 266 Japanese subjects with osteoporosis Trial met its 1EP, with SPD8 demonstrating therapeutic equivalence to Prolia. The between-group difference in the 1EP & its 95% confidence interval fell within the pre-specified…

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GlycoNex Doses Last Patient in P-III Trial of SPD8 (Biosimilar, Prolia/Xgeva) to Treat Osteoporosis

Shots: GlycoNex has dosed the last patient with SPD8, a biosimilar version of Prolia/Xgeva (denosumab), in its P-III trial for the treatment of primary osteoporosis from solid tumors Trial will assess the PK, efficacy, & safety of SPD8 vs reference denosumab in postmenopausal women with osteoporosis; top-line results are expected in Q2’26 & data will support…

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GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)

Shots: GlycoNex has reported a licensing agreement to develop SPD8, a biosimilar version of Amgen’s Prolia and Xgeva (denosumab) The licensee will secure rights for the development, regulatory activities & commercialization of SPD8 in the designated regions. The deal includes development and commercial milestones, supporting GlycoNex's global business operations SPD8 is under P-III…

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GlycoNex Reports the Completion of P-I Study Assessing SPD8 (Biosimilar, Prolia) for Osteoporosis 

  Shots:  GlycoNex, in partnership with Mitsubishi Gas Chemical Company, has concluded the P-I trial assessing SPD8, biosimilar version of Prolia (denosumab), for treating osteoporosis. Both the companies have completed the P-I study across Japan  Based on these results, SPD8 will proceed to P-III trial aimed at assessing its efficacy, safety & immunogenicity among larger…

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