Biosimilar Development News
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Xbrane Provides Regulatory Update On FDA Review Of Its Ranibizumab Biosimilar Candidate
5/2/2024
Xbrane Biopharma AB (“Xbrane”), a leading Swedish biosimilar developer, announce that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate (development name Xlucane) for treatment of retinal disorders.
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US FDA Approves High-Concentration, Citrate-Free Formulation Of Cyltezo® (adalimumab-adbm) Injection, Boehringer Ingelheim's Interchangeable* Biosimilar To Humira®
5/1/2024
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's interchangeable* biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases.
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Sandoz Reaches Agreement With Amgen Resolving All Patent Litigation Related To Its US Denosumab Biosimilars
4/30/2024
Sandoz, the global leader in generic and biosimilar medicines, today announced that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz denosumab biosimilars.
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U.S. Commercialization Agreement With Quallent To Drive Patient Savings With First High-Concentration Citrate-Free Interchangeable Biosimilar To Humira (adalimumab)
4/30/2024
Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., disclosed today that under the recently announced U.S. strategic partnership agreement, Alvotech will manufacture its high-concentration interchangeable biosimilar to Humira (adalimumab) for Quallent Pharmaceuticals with, in alignment with its U.S. commercialization agreement with Teva.
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Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval Of HERCESSI™ (trastuzumab-strf), A Biosimilar To Herceptin® (trastuzumab) For The Treatment Of Several Forms Of HER2-Overexpressing Cancer
4/29/2024
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.
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Henlius Trastuzumab Receives FDA Approval In The United States
4/26/2024
Shanghai Henlius Biotech, Inc. announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI (HLX02, trastuzumab-strf, biosimilar to Herceptin trade name: HANQUYOU in China and Zercepac in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius.
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Biogen Receives Positive CHMP Opinion For TOFIDENCE™ (tocilizumab), A Biosimilar Referencing ROACTEMRA®
4/25/2024
Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1.
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Evernorth Announces Humira Biosimilar Available At $0 Out Of Pocket For Accredo Patients In June
4/25/2024
In an important step toward driving long-term affordability and access to treatments for chronic and complex conditions, Evernorth Health Services announced that it will have a Humira® biosimilar available for $0 out of pocket for eligible patients of its specialty pharmacy Accredo beginning this June.
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Alvotech Announces Topline Results From A Confirmatory Clinical Study For AVT05, A Proposed Biosimilar For Simponi® (golimumab)
4/24/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab).
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Samsung Bioepis Gains European Commission Approval For PYZCHIVA7™, A Biosimilar To Stelara (Ustekinumab)
4/22/2024
Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.