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FDA Approves BLA for Novavax’s COVID-19 Vaccine

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On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more

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Recent Biosimilar Commercialization Developments

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​​​​​​​Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

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Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

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Biogen/Samsung Approval of BYOOVIZ™

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Samsung Bioepis, Co. Ltd. and Biogen Inc. announced yesterday that their biosimilar product BYOOVIZ™ (ranibizumab-nuna) was approved by FDA.  BYOOVIZ™ is a biosimilar to LUCENTIS®, which is indicated for the treatment of...more

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Teva and Celltrion Launch Rituximab Biosimilar in US

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On November 7, Teva Pharmaceuticals USA, Inc., and Celltrion, Inc., announced that TRUXIMA® (rituximab-abbs) will be available in the United States beginning November 11. As we previously reported, TRUXIMA® is the first...more

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