Tagged as: Genentech

Genentech and Samsung Bioepis Settle Bevacizumab Biosimilar Patent Dispute

As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Samsung’s submission of an aBLA for SB8, a proposed biosimilar of AVASTIN (bevacizumab). On September 7, 2022, Genentech and Samsung filed…

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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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FDA Approves Amgen’s RIABNI™ (Rituximab-arrx) for Adults With Moderate to Severe Rheumatoid Arthritis

On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA).  RIABNI has been approved since December 2020 for treatment of adult patients with…

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FDA Approves Genentech’s VABYSMO for Wet AMD and Diabetic Macular Edema

On January 28, 2022, the Food and Drug Administration (FDA) approved Genentech’s VABYSMO (faricimab-svoa) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). According to the Genentech press release, VABYSMO targets and neutralizes angiopoietin-2 (ang-2) and vascular endothelial growth factor-A (VEGF-A). The press release also…

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FDA Approvals and Applications Update

On October 22, 2021, the FDA approved Genentech’s SUSVIMO (ranibizumab injection) for wet age-related macular degeneration (AMD) based on positive results from an open-label Phase III study. According to the Genentech press release, SUSVIMO, previously called Port Delivery System with ranibizumab, offers an alternative route of administration for anti-VEGF in…

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Fresenius Files IPR Petitions Challenging Chugai/Roche/Genentech Rheumatoid Arthritis Patents

On August 18, 2021, Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH (collectively, “Fresenius”) filed Petitions for Inter Partes Review of U.S. Patent No. 10,874,677 (IPR 2021-01336) and U.S. No. 5,80,264 (IPR 2021-01288) .  The ‘264 patent claims are directed to methods of treating rheumatoid arthritis patients using a…

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