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Celltrion’s CT-P6 Demonstrates Equivalent Safety, Efficacy With HERCEPTIN

A recently-published study reported that Celltrion’s CT-P6 (HERZUMA, trastuzumab-pkrb) demonstrated equivalent safety and efficacy compared with reference drug HERCEPTIN when used to treat patients with HER2-positive advanced gastric cancer.  This is the first study to directly compare the safety and efficacy of CT-P6 against HERCEPTIN in patients with advanced gastric…

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RELEUKO Receives FDA Approval

Amneal Pharmaceuticals and Kashiv Biosciences have announced that their RELEUKO (filgrastim-ayow) biosimilar recently received FDA approval, making it the third filgrastim biosimilar approved for the United States, as well as the FDA’s first biosimilar approval this year.  RELEUKO references Neupogen®, and is expected to launch in the third quarter of…

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Innovent Announces Results of Phase III Trial of Sintilimab and Bevacizumab Combination Therapy In Patients With Advanced Lung Cancer

Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer.  According to the press release, patients receiving sintilimab plus BYVASDA combined with chemotherapy (pemetrexed and cisplatin) demonstrated an improvement in progression-free…

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FDA Approves First Interchangeable Biosimilar Insulin Product (UPDATE - 11/23/2021)

July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…

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