Celltrion recently announced that it will start selling Yuflyma, an adalimumab biosimilar, in the U.S. in July 2023. The announcement stems from Celltrion’s recently inked patent agreement with AbbVie which allows Celltrion to market a high-concentration formulation of the drug. As a company official stated, “By entering the U.S. market…
Alvotech Holdings S.A. (“Alvotech”) announced today that it has resolved all intellectual property disputes with AbbVie in Europe related to Alvotech’s AVT02 (adalimumab) biosimilar candidate. This announcement follows Alvotech’s announcement last month that the company had settled its pending disputes related to AVT02 with AbbVie in the U.S., and states…
On March 30, 2022, Medytox filed a complaint with the ITC requesting that the ITC block imports of Hugel’s follow-on biologic Letybo® (LetibotulinumtoxinA) product. The complaint alleges that Hugel expects to obtain approval and launch its product in the U.S. in 2022. The complaint alleges that “Hugel misappropriated Medytox’s trade…
Alvotech Holdings S.A. (“Alvotech”) has announced that they have settled all pending disputes between AbbVie and Alvotech related to AVT02 (100mg/mL), Alvotech’s high-concentration, citrate-free biosimilar candidate for Humira® (adalimumab). The announcement states that under the settlement agreement, Alvotech has non-exclusive rights to market AVT02 in the United States starting July…
On February 18, 2022, in the first and second wave suits filed by AbbVie Inc. et al. (AbbVie) against Alvotech hf. (Alvotech) regarding an adalimumab biosimilar, AbbVie filed a motion to strike Alvotech’s Final Invalidity and Unenforceability Contentions and a memorandum in support thereof. AbbVie moved the Court to strike…
On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech. The biosimilar, also referred to as AVT02, will be marketed in Canada as SIMLANDI (100 mg/mL…
Earlier this year, AbbVie Inc. and AbbVie Biotechnology Ltd. filed a Complaint against Alvotech hf. in the US District Court for the Northern District of Illinois alleging theft of trade secrets relating to adalimumab. In October, AbbVie’s complaint was dismissed for lack of personal jurisdiction. AbbVie has appealed that ruling. In addition…
On September 20, 2021, the District Court for the Northern District of Illinois entered a scheduling order in AbbVie v. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.). As we previously reported, AbbVie Inc. (“AbbVie”) brought an action on April 27, 2021, in the Northern District of Illinois for patent infringement against…
An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two adalimumab biosimilars, ABP501 (Amgen) and SB5 (Samsung Bioepsis). The authors concluded from this study that both biosimilars…
On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia. As readers of this blog may recall, in September 2020, Alvotech USA filed a BLA for AVT02, a…