Tagged as: Tanvex

Genentech BPCIA Trastuzumab Case Against Tanvex Dismissed After Settlement

As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab).  On February 9, the court entered an order dismissing all claims in the case.  Tanvez’s trastuzumab biosimilar has not yet been approved by FDA. Genentech previously settled…

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Genentech and Tanvex Reach Settlement in Principle in Trastuzumab BPCIA Litigation

On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint.  As we previously reported, Genentech filed a complaint against Tanvex in June 2022, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA…

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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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