Tagged as: Pegfilgrastim

Coherus Biosciences Announces Approval of a Pegfilgrastim Autoinjector

On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was first launched in the US in January 2019 and is one of six FDA approved pegfilgrastim biosimilars. Udenyca is administered the day after a chemotherapy treatment…

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Fresenius Kabi Launches STIMUFEND (pegfilgrastim-fpgk) in the United States

Last week, Fresenius Kabi announced the launch of STIMUFEND (pegfilgrastim-fpgk), a biosimilar to Amgen’s NEULASTA, in the United States.  As we previously reported, STIMUFEND was Fresenius Kabi’s first biosimilar approved by the FDA on September 6, 2022 and is now Fresenius Kabi’s first biosimilar to launch in the United States. …

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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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Fresenius Kabi Announces FDA Approval of Pegfilgrastim Biosimilar

On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  The company states that it expects to launch the product in…

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Amneal Announces FDA Acceptance of aBLA for Bevacizumab

Amneal Pharmaceuticals, Inc., a fully integrated pharmaceutical company headquartered in Bridgewater, NJ, announced last week that the U.S. FDA has accepted its aBLA seeking approval of a biosimilar of Avastin® (bevacizumab).  This biosimilar was developed in collaboration with Spain-based biopharmaceutical company mAbxience, which had obtained approval earlier this year to…

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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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Lupin Announces FDA Acceptance of aBLA for Pegfilgrastim Biosimilar

Global pharmaceutical company Lupin Limited recently announced that the U.S. FDA has accepted its aBLA for a proposed pegfilgrastim biosimilar (reference product Neulasta®).  Lupin reported that the aBLA submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.  Company CEO Vinita Gupta commented, “FDA’s acceptance of our…

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White Paper Investigates Biosimilar Competition and Price Reduction

In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and Innovation Act (BPCIA) and moderation in drug prices driven by market competition.  The white paper studied the price and…

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