Many pre-commercialization gene or cell therapy companies are aware of the patents that could threaten their product after launch, but assume that they are protected from patent infringement suits before they obtain FDA approval and sell their products under the so-called “safe harbor.” In this webinar on August 2, 2023,…
As we previously reported, in December 2022, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc. This week Biocon announced that it had “completed the integration of the acquired biosimilars business in over 70 countries in Emerging…
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb). With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…
Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter (“CRL”) for its aflibercept 8 mg BLA for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, “due to an ongoing review of inspection findings at a…
Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States. Boehringer Ingelheim has also announced that with CYLTEZO’s commercial launch, pharmacy-benefit manager Optum Rx (a subsidiary of UnitedHealth Group), which currently covers more than 66…
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s submission in October 2021. As…
Last week REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging that the defendants’ adeno-associated virus (“AAV”) technology gene therapy product has infringed or will infringe U.S. Patent No. 11,680,274 (“the ‘274 Patent”)….
On June 21, 2023, Xbrane announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Xbrane’s supplemental Biologics License Application (sBLA) for a LUCENTIS® (ranibizumab) biosimilar candidate. Xbrane stated that “[t]he biosimilar candidate is a VEGF-a inhibitor, intended for the treatment of serious eye diseases such as…
Our readers may recall that ten HUMIRA biosimilars have been licensed to launch, with Amgen’s AMJEVITA the only one to launch to date and nine others set to launch starting in July 2023. On June 1, 2023, Coherus issued a press release announcing “that the company plans to launch YUSIMRY™…
Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims 1-3 of U.S. Patent No. 9,718,880; IPR2023-00999, challenging claims 1-10 of U.S. Patent No. 9,725,504; IPR2023-01069, challenging claims 1-8 of U.S. Patent No. 10,590,189; and IPR2023-01070, challenging…