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Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

Shots: Accord BioPharma has reported the launch of Osvyrti & Jubereq, interchangeable biosimilars to Amgen’s Prolia & Xgeva (denosumab), in the US Osvyrti (60mg PFS) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer…

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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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Henlius & Organon

Organon and Henlius Launch Bildyos and Tuzemty (Biosimilars, Prolia and Xgeva) in Canada

Shots: Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty Denosumab is a mAb that works…

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Abbott

Abbott Receives ANVISA’s Approval for Two Denosumab Biosimilars (Biosimilars, Prolia and Xgeva) 

Shots:  The ANVISA has approved two denosumab biosimilars (60 mg and 120 mg), a biosimilar version of Prolia and Xgeva in Brazil, expanding access to treatments for osteoporosis and cancer-related bone complications  The P-III SIMBA study confirms that Abbott's MB09 denosumab biosimilar demonstrates efficacy and safety comparable to the reference biologic, providing equivalent protection against bone loss in postmenopausal women  In 2023, mAbxience and Abbott partnered to develop, manufacture, and supply denosumab biosimilars,…

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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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Key Biosimilars Events of April 2026 

Shots:  Regulatory momentum stayed strong in April 2026, with key approvals including Poherdy (EC), Tuyory (EC), and multiple denosumab biosimilars in Canada, alongside NMPA IND clearances for Henlius’ HLX319 and HLX05-N and Mabwell’s Maiweijian sBLA acceptance.  Strategic activity expanded globally through Mochida–Qilu and Mabwell partnerships, while major M&A deals, Amneal–Kashiv and Sun Pharma–Organon, signaled growing biosimilar consolidation.  Pipelines and commercialization progressed with CuraTeQ’s P-III success for BP11 and Biocon’s US launch of Bosaya and Aukelso,…

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Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)

Shots: Health Canada has granted NOC to Biocon's Bosaya (60mg/mL, SC, PFS) & Vevzuo (70mg/mL, SC, single-dose vial), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) Approval was based on extensive data, incl. analytical, nonclinical, & clinical data, showing that both biosimilars matched the reference product in quality, safety & efficacy Bosaya & Vevzuo are anti-RANKL monoclonal…

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Mabwell  Collaborates with a Strategic Business Partner to Commercialize of Mailishu and Maiweijian (Biosimilar, Prolia and Xgeva) in Malaysia   

Shots:  Mabwell has entered a licensing and commercialization agreement with a Malaysian partner for its denosumab biosimilars, Mailishu (biosimilar, Prolia) and Maiweijian (biosimilar, Xgeva)  As per the deal, the partner will handle registration and commercialization in Malaysia  While Mabwell will oversee the development, manufacturing, and supply of the products  Ref: Mabwell |  Image:  Mabwell |  Press Release Related News:  Mabwell Initiates P-III Trial for 9MW2821 in TNBC…

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Mabwell  Reports NMPA’s sBLA Acceptance of Maiweijian (Biosimilar, Xgeva) 

Shots:  The NMPA has accepted the sBLA of Maiweijian (Denosumab; 120mg), a biosimilar version of Xgeva, developed by its subsidiary T-mab, for preventing skeletal-related events in multiple myeloma and bone metastases from solid tumors  Maiweijian is China’s first approved 120 mg denosumab biosimilar, initially cleared in March 2024 for adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery may…

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