Tagged as: filgrastim

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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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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ASH Presentations Show Benefits of Biosimilar Pegfilgrastim Over On-Body Injector

Investigators presented two studies on Monday at the American Society of Hematology Annual Meeting and Exposition (ASH) showing the potential for significant cost-savings by switching to biosimilar pegfilgrastim from the pegfilgrastim on-body injector (PEG-OBI). In one study, investigators demonstrated a potential for savings from a conversion to several biosimilar filgrastim…

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Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue.  It reported the following YoY revenue for each…

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Filgrastim PTAB Update

As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system.  Amgen is asserting the ’878 and…

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BREAKING NEWS: Federal Circuit Affirms Sandoz’s Victory Over Amgen in Filgrastim and Pegfilgrastim Biosimilar Patent Litigation

This morning, the Federal Circuit issued a precedential opinion affirming the district court’s judgment of non-infringement in favor of Sandoz in its BPCIA litigation against Amgen concerning Sandoz’s Zarxio® (filgrastim-sndz) biosimilar product and proposed pegfilgrastim biosimilar.  As we previously reported, in December 2017 the Northern California district court granted summary…

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PTAB Institutes PGR of Protein Refolding Patent at Issue in Filgrastim and Pegfilgrastim Litigations

U.S. Patent No. 9,856,287, which is directed to a protein refolding method, is one of the patents-in-suit in the pending Amgen v. Adello (filgrastim) BPCIA litigation and the sole patent-in-suit in the pending Amgen v. Apotex (filgrastim and pegfilgrastim) BPCIA litigation. As we previously reported, in November 2018, Adello and…

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Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…

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Tanvex’s New Drug Submission for Filgrastim Biosimilar to Health Canada

BioSimilars Patent Dance

Last October, we reported that Taiwan-based Tanvex BioPharma (“Tanvex”) announced that it had submitted a BLA to the FDA seeking approval of TX-01, a proposed biosimilar referencing Neupogen® (filgrastim) indicated for chemotherapy induced neutropenia. Last November, the FDA accepted Tanvex’s BLA for its filgrastim biosimilar. This week Tanvex has submitted a New Drug Submission (NDS) to…

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