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Henlius & Organon
NEWS

Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Shots: The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…
3 days ago

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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

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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CuraTeQ
NEWS

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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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

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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NEWS

Bio-Thera Expands Collaboration with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) in India 

Shots:  Bio-Thera Solutions expanded its partnership with Intas Pharmaceuticals for BAT2506, a proposed biosimilar of Simponi (golimumab), through an exclusive commercialization and licensing agreement for India  BAT2506 is a proposed golimumab biosimilar by Bio-Thera. Golimumab, a human IgG1 monoclonal antibody, targets TNF-α to reduce key inflammatory markers such as CRP, IL-6, ICAM-1, MMP-3, and VEGF. The reference drug is approved…
March 23, 2026

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