Tagged as: Bevacizumab

Celltrion Obtains Canadian Approval To Sell Bevacizumab Biosimilar

This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma.  Celltrion has secured sales licenses for Vegzelma in 35 countries,…

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Biocon Biologics Confirms Completion of Multi-Billion Dollar Acquisition of Viatris’ Global Biosimilars Business

As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…

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FDA Accepts Outlook Therapeutics' BLA for Ophthalmic Bevacizumab

Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).  There are no FDA-approved ophthalmic formulations of bevacizumab currently…

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Amneal Launches Bevacizumab Biosimilar in the United States

Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States:  ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech’s AVASTIN product.  ALYMSYS is a vascular endothelial growth factor inhibitor approved by the FDA in April 2022 for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent…

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Celltrion’s Bevacizumab Biosimilar Approved by FDA

Celltrion announced this week that the FDA has approved VEGZELMA (bevacizumab-adcd), a biosimilar to AVASTIN, for treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian…

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Biocon and Alvotech Release Statements on FDA Inspections

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.  The inspections took place between August 11 and August 30, 2022.  The inspections were triggered by three preapproval inspections…

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Outlook Therapeutics Re-Submits Its Ophthalmic Bevacizumab BLA

On August 30, 2022, Outlook Therapeutics, Inc. announced that it has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, “an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).”   As we previously reported, Outlook…

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Prestige Biopharma and Intas Pharmaceuticals Partner on Bevacizumab Biosimilar

On July 26, Prestige Biopharma Limited (“Prestige”) announced a partnership with Intas Pharmaceuticals Limited (“Intas”) and its affiliate Accord Healthcare to commercialize Prestige’s bevacizumab, HD204, a proposed biosimilar to Roche’s AVASTIN®, in the United States, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan, and…

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Outlook Therapeutics to Revise Ophthalmic Bevacizumab BLA in Light of FDA Request

Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA.  LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection formulation of bevacizumab for the treatment of wet AMD and other retinal diseases.  In response to FDA’s request, Outlook…

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