Tagged as: Tanvex

Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree “to the dismissal, without prejudice, of all remaining claims and counterclaims in…

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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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