Tagged as: Genentech

International Biosimilar Launches: Ujvira and PrInclunox®

On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar.  The drug is a trastuzumab emtansine biosimilar—using Genentech’s Kadcyla as the reference product—that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer.  The drug is made…

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Genentech Sues Centus Over Proposed Bevacizumab Biosimilar

Yesterday, Genentech, Inc. filed a complaint in the Eastern District of Texas alleging that Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents.  Genentech’s complaint, styled as a Complaint for…

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Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court Order in Response Asks Parties to Answer Questions

On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…

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Genentech v. JHL case schedule extended

As we previously reported, Genentech and JHL Biotech reached a settlement agreement resolving the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products.  However, the case continued against the four former Genentech employees as individual defendants, although…

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Biologic and Biosimilar Approval Updates

The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…

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Special Master Appointed to Decide Requests to Seal and Redact in Genentech v. Amgen BPCIA Litigations

On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the parties’ requests to seal various court filings.  Judge Connolly stated that “[r]ecent sealed and redacted filings in these related cases make clear that…

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Russian Pharma Company Biocad Obtains European Certification for Biosimilars to Treat Cancer

On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars:  Acellbia (rituximab), a biosimilar of Roche’s MabThera®, and Herticad (trastuzumab), a biosimilar of Roche’s Herceptin®.  According to Biocad, the registration…

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District Court of Delaware Construes “Following Fermentation” in Genentech v. Amgen Trastuzumab and Bevacizumab Cases

We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to U.S. Patent No. 8,574,869 (“the Kao patent”) to mean “after the earlier of harvesting or purification has begun.” By way of…

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