On May 24, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Alvotech notes that its trial…
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…
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 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…
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie moved to dismiss Alvotech’s counterclaims and affirmative defenses of inequitable conduct, unclean hands, and patent…
On Friday, October 22, 2021, Judge Raymond A. Jackson of the Eastern District of Virginia (E.D. Va.) transferred Alvotech USA and Alvotech hf.’s (jointly, “Alvotech”) declaratory judgment suit against AbbVie Inc. and AbbVie Biotechnology Ltd. (jointly, “AbbVie”) to the Northern District of Illinois (N.D. Ill.) and dismissed AbbVie’s pending motion…
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…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). Humira® is approved to treat certain inflammatory conditions. Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s…
On June 15, 2021 Alvotech announced that data collection has been completed from the last of its 568 clinical trial study participants in AVT02-GL-302, a switching study for AVT02, the company’s biosimilar to high concentration (100mg/mL) Humira®. The switching study compared the pharmacokinetics, efficacy, safety, and immunogenicity of AVT02 (40…