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Venable LLP

FDA Approves Biocon’s Avastin® Biosimilar Jobevne™ (bevacizumab-nwgd)

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On April 10, 2025, Biocon announced the FDA approval of Jobevne™ (bevacizumab-nwgd) as the sixth biosimilar of Genentech’s Avastin® (bevacizumab)...more

Goodwin

FDA Approves Biocon Biologics’ Bevacizumab Biosimilar

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On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE™ (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech’s AVASTIN®.  JOBEVNE™ is a...more

Goodwin

Recent Biosimilar Approvals By the FDA

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Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN...more

Goodwin

FDA Approves VABYSMO (faricimab) for Retinal Vein Occlusion

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​​​​​​​On October 26, 2023, Genentech, a member of the Roche Group, announced that the FDA approved VABYSMO (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). ...more

Goodwin

FDA Approvals and Applications Update

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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...more

Herbert Smith Freehills Kramer

Biosimilars in 2020: What’s Ahead

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The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Goodwin

Year in Review: The Top-Five U.S. Biosimilar Market Developments of 2019

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As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more

Goodwin

FDA Approves New Trastuzumab Product

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On February 28, 2019, the FDA approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk). According to a press release from Roche, Genentech’s parent company: “This new treatment includes the same monoclonal...more

Goodwin

Year in Review: The Top-Five U.S. Market Developments of 2017

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Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Goodwin

FDA Approves Genentech’s Ocrevus (ocrelizumab)

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FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug...more

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