Tagged as: Biosimilars News

Tanvex receives Complete Response Letter from FDA for its Proposed Filgrastim Biosimilar Product

On September 25, 2019, Tanvex BioPharma announced that it received a complete response letter from the U.S. FDA indicating that Tanvex’s abbreviated Biologics License Application (aBLA) for its proposed filgrastim biosimilar, TX01, was not in condition for approval. Tanvex reported that FDA “did not request additional clinical data or express…

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Biocad and Shanghai Pharma Holding Announce Joint Venture in China

Last month, Biocad and Shanghai Pharma Holding (SPH) announced that they have established a joint venture, SPH-Biocad, to commercialize Biocad’s biopharmaceutical portfolio in China. According to the companies’ press releases, SPH-Biocad will begin by commercializing six of Biocad’s biopharmaceutical products, including three biosimilars and three innovative biologics. According to SPH,…

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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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Amneal, Amgen, and Kashiv jointly stipulate to dismiss patent in filgrastim litigation

As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…

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Biosimilar Development Update: Mochida, Celltrion, Innovent, DRL, Fresenius

Below are some highlights of recent biosimilar development news from this week:   On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. …

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