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INSIGHTS+

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,…
May 5, 2026

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NEWS

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…
April 21, 2026

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NEWS

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…
April 16, 2026

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NEWS

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…
April 15, 2026

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NEWS

Apotex Receives Health Canada Approval for Denoza (Biosimilars, Prolia) 

Shots:  Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia  Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph  Denoza will be available in a prefilled syringe format  Ref: Apotex | Image: Apotex | Press Release…
April 7, 2026

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NEWS

Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance

Shots: The US FDA has approved Ponlimsi, a biosimilar version of Prolia (denosumab), for all indications of the reference product Approval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to the reference product Additionally, Teva’s biosimilar of Xolair (omalizumab) was accepted for review…
March 31, 2026

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NEWS

Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval 

 Shots:  The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva  Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications   Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights  Ref: Amneal Pharmaceuticals| Image: Amneal Pharmaceuticals and mAbxience | Press Release Related News:- Kashiv BioSciences and Amneal…
December 22, 2025

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Samsung Bioepis
NEWS

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on…
December 1, 2025

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