Tagged as: Pegfilgrastim

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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Amneal Launches FYLNETRA (pegfilgrastim-pbbk) in the United States

Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States.  According to the press release, FYLNETRA—Amneal’s third biosimilar launch in the United States since late last year—is used to treat neutropenia (low neutrophils, a type of white blood cell that fights infection)…

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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 Achieves Third U.S. Biosimilar Approval with FYLNETRA (pegfilgrastim-pbbk)

Amneal announced today that the U.S. Food and Drug Administration has approved its Biologics License Application for FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing NEULASTA®.  FYLNETRA, developed in collaboration with Kashiv Biosciences, LLC, is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which…

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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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