Biosimilar Development News
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Dong-A ST Secures European Approval For Stelara Biosimilar IMULDOSA
12/19/2024
Dong-A ST proudly announces that its Stelara biosimilar, IMULDOSA (Project Name: DMB-3115, Active Ingredient: Ustekinumab), has received marketing authorization from the European Commission (EC) as of December 18.
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Glyconex Announces First Patient Dosed In Phase 3 Clinical Trial For Denosumab Biosimilar
12/17/2024
GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that the first patient has been dosed in the Phase 3 clinical trial of its denosumab biosimilar, SPD8.
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U.S. FDA Approves Celltrion's STEQEYMA® (ustekinumab-stba), A Biosimilar To STELARA® (ustekinumab)
12/17/2024
Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis.[1]
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Bio-Thera Solutions Expands Partnership With SteinCares In LATAM With Addition Of A Third Biosimilar To Partnership
12/16/2024
Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars today announced an expansion of their partnership with SteinCares today with the addition of a third biosimilar to the partnership.
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Celltrion Receives Positive CHMP Opinion For Three Biosimilars In The European Union
12/15/2024
Celltrion today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions and recommended marketing authorisations for three biosimilar candidates: Eydenzelt (CT-P42, aflibercept), Stoboclo and Osenvelt (CT-P41, denosumab), and Avtozma (CT-P47, tocilizumab).
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Biosimilars Forum Welcomes Henlius As Newest Member
12/12/2024
The Biosimilars Forum has announced Henlius (2696.HK), a global biopharmaceutical company, as its newest member.
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Health Canada Approves Celltrion's Omlyclo (CT-P39), The First And Only omalizumab Biosimilar In Canada
12/9/2024
Celltrion today announced that Health Canada has approved Omlyclo, a biosimilar referencing Xolair. Omlyclo is approved for the treatment of adults and adolescents with chronic idiopathic urticaria (CIU), also called chronic spontaneous urticaria (CSU), adult and pediatric patients with allergic asthma, and adults with chronic rhinosinusitis with nasal polyps (CRSwNP).1
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ASBM Responds To PCMA: Put Patients First, Not PBM Profits
12/9/2024
As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust.
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Latest Results Of 5 Clinical Trials Released At ESMO Asia 2024
12/9/2024
Recently, results from five clinical trials of Henlius' self-developed products, including novel anti-PD-1 mAb HANSIZHUANG (serplulimab), anti-EGFR mAb HLX07 and daratumumab biosimilar candidate HLX15, were released at European Society for Medical Oncology Asia (ESMO Asia) Congress 2024.
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Xbrane Re-Submits BLA For Ranibizumab Biosimilar Candidate To FDA
12/3/2024
Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to FDA (US Food and Drug Administration).