Tagged as: Amgen

FDA Approves Amneal’s ALYMSYS (bevacizumab-maly)

On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN.  The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…

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Amgen and Pfizer Developing More Interchangeable Biosimilars

In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars.  Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab).  Pfizer also…

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American Academy of Ophthalmology Pushes Back Against Bevacizumab Biosimilar Use in Treating Ophthalmic Conditions

On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases.  The statement alleges that certain large healthcare…

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Amgen v. Hospira Pegfilgrastim Case Stayed Pending Potential Summary Judgment Practice

On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim).  In the Order, the Court construed the term “between about 0.1 M…

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