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NEWS

Mochida Pharmaceutical Collaborates with Qilu Pharmaceutical to Develop & Commercialize of Follitropin Alfa (Biosimilar, Gonal‑f) Across Japan 

Shots:  Mochida Pharmaceutical has entered into a development and commercialization agreement with Qilu Pharmaceutical for a biosimilar of follitropin alfa in Japan  As per the deal, Mochida will lead development to secure marketing approval in Japan, collaborating with Qilu for early launch, and strengthening its position in Japan’s biosimilar market  Follitropin alfa is a recombinant FSH used for…
April 15, 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

Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)

Shots: The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC) HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions Cetuximab is an anti-EGFR monoclonal…
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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CuraTeQ
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CuraTeQ Reports P-III Trial Data on BP11 (Biosimilar, Xolair) in Chronic Spontaneous Urticaria

Shots: CuraTeQ Biologics has reported topline P-III trial data assessing BP11, a biosimilar version of Xolair (omalizumab) vs Xolair in pts with chronic spontaneous urticaria Trial met its 1EPs in CSU at 300mg, evaluating ISS7 changes at Wk. 12 across 608 pts at ~80 sites, demonstrating equivalence between BP11 & Xolair within predefined margins Additionally,…
April 7, 2026

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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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Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Shots: Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…
March 24, 2026

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