Biosimilar Development News
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Sandoz Receives FDA Approval For Enzeevu (aflibercept-abzv), Further Strengthening US Biosimilar Position
8/12/2024
Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection.
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Introducing Jubbonti And Wyost, The First denosumab Biosimilars On The Canadian Market
8/12/2024
Sandoz Canada, a leader in generics and biosimilars, today announces the launch of two denosumab biosimilars: Jubbonti® and Wyost®.
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Celltrion USA Announces Incorporation Of Adalimumab-aaty, A Humira® Biosimilar, To The Costco Member Prescription Program
8/12/2024
Celltrion USA, Inc., (Celltrion USA) today announced its FDA-approved biosimilar adalimumab-aaty, has been added to the Costco member prescription program. Adalimumab-aaty is a high-concentration (100mg/mL) and citrate-free biosimilar to Humira® (adalimumab).
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Xbrane Provides Update On The Ongoing Out-Licensing Of Xdivane (nivolumab Biosimilar Candidate) And XB003 (Cimzia Biosimilar Candidate) And Its Financial Position
8/12/2024
As communicated on 1 August 2024 and given the previously communicated delay in FDA approval of Ximluci and the unforeseen termination of the license agreement with Biogen, Xbrane Biopharma AB (publ) ("Xbrane" or the "Company”) has initiated a process to out-license both Xdivane and XB003 for purposes of ensuring financing until envisioned positive operational cash-flow in Q2 2025.
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Xbrane To Regain Full Rights To BIIB801, A Proposed Biosimilar Referencing CIMZIA
8/9/2024
Xbrane Biopharma (publ) ("Xbrane" or the "Company") today announced they will regain full rights to BIIB801 following a decision by Biogen Inc.to terminate the commercialization and license agreement between the companies.
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Henlius To Release Latest Results Of HANSIZHUANG And HANQUYOU At ESMO Congress 2024
8/7/2024
2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain.
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Manitoba Announces Transition To Cost-Saving Biosimilar Medicines
8/6/2024
Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, welcomes the announcement by the Government of Manitoba that it has implemented a “switching” or transitioning policy to expand the use of cost-saving biosimilar biologic medicines.
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Lupin Announces Successful Completion Of Phase 3 Trials For Lucentis Biosimilar
8/5/2024
Global Pharma major Lupin Limited (Lupin) today announced the successful completion of a global Phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis.
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Boan's Dulaglutide Cleared By FDA For Clinical Trials
8/5/2024
Boan Biotech today announced that it has received the U.S. FDA clearance for clinical trials of its dulaglutide injection (BA5101). BA5101 is a proposed biosimilar to Trulicity intended for glycemic control in patients with type 2 diabetes.
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Health Canada Approves Celltrion's Steqeyma, A Biosimilar To Stelara (ustekinumab) For The Treatment Of Multiple Chronic Inflammatory Conditions
8/1/2024
Celltrion Healthcare Canada Limited today announced that Health Canada has approved Steqeyma (ustekinumab injection) and Steqeyma I.V. (ustekinumab for injection, solution for intravenous infusion) for the treatment of moderately to severely active Crohn’s disease in adults, moderate to severe plaque psoriasis in adult patients, and active psoriatic arthritis.1