Biosimilar Development News
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Altos Biologics Files For Approval Of Aflibercept Biosimilar
7/1/2024
Alteogen Inc. (KOSDAQ: 196170) announced on July 1st that its subsidiary, Altos Biologics Inc. has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for an aflibercept biosimilar ALT-L9, developed by Alteogen.
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FDA Approves PYZCHIVA (ustekinumab-ttwe), Samsung Bioepis' Biosimilar To Stelara
7/1/2024
Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA® (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Stelara1 (ustekinumab).
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Tanvex Received BLA Approval From FDA
7/1/2024
Tanvex BioPharma, Inc. announced that The U.S. Food and Drug Administration (FDA) had completed their review of our submission of NYPOZI (TX01) and approved the biologics license application (BLA) on June 28, 2024.
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Henlius Announces Successful Completion Of Phase 1 Clinical Study Of Daratumumab HLX15
6/28/2024
Shanghai Henlius Biotech, Inc. announced that a phase 1 clinical trial (NCT05679258) of the company’s daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection, met its primary endpoint.
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Meitheal Pharmaceuticals Strengthens Biologics Portfolio With An Exclusive Commercial Licensing Agreement For YUSIMRY, A Biosimilar Of Humira
6/27/2024
Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has gained exclusive commercial rights in the U.S. to YUSIMRY (adalimumab-aqvh), a biosimilar of Humira (adalimumab), through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (“HKF”).
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TOFIDENCE™ (tocilizumab), A Biosimilar Referencing ROACTEMRA®, Approved In The European Union
6/24/2024
Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA®1.
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FDA Accepts Professor Niazi's Petition To Allow Interchangeable Status To Biosimilars Without Additional Clinical Testing--A Rational Step Towards Removing Misconceptions About Biosimilars
6/24/2024
According to Pharmaceutical Scientist, Inc., biosimilars are copies of biological drugs introduced after the expiry of the patents or exclusivity of new biological drugs as a more affordable choice for patients.
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EMA Approves Biocon Biologics' New Mabs Facility In India And Renews GMP Certifications For India And Malaysia Sites
6/24/2024
Biocon Biologics Ltd (BBL), a global, fully integrated biosimilars company and a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru.
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Pharmaforce International: Benchmarking Report Captures Key U.S. Immunology Companies' Strategic Responses To The 2023 Biosimilar Approvals
6/19/2024
PharmaForce International (PFI) publishes a yearly competitive intelligence report benchmarking the commercial operations of leading Immunology sales and marketing organizations in the United States.
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Alvotech And ADVANZ PHARMA Sign Commercialization Agreement For Proposed Biosimilar To Eylea LD/HD In Europe
6/18/2024
Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and ADVANZ PHARMA, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech’s proposed biosimilar to Eylea (aflibercept).