Tagged as: Bevacizumab

Biocon Completes Integration of Viatris Biosimilars Business

As we previously reported, in December 2022, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc.  This week Biocon announced that it had “completed the integration of the acquired biosimilars business in over 70 countries in Emerging…

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FDA Issues CRL for Biocon/Viatris Bevacizumab Biosimilar

On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by Viatris.  Biocon Biologics completed the multi-billion dollar acquisition of Viatris’s global biosimilar business in December 2022.  The CRL relates…

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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

Bottle of Pills and a FDA APPROVED rubber stamp

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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