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…
As noted in our December 21, 2021 post, Complainants AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. Ltd. filed a complaint at the International Trade Commission against Respondents Alvotech hf., Alvotech Germany GmbH, Alvotech Swiss AG, Alvotech USA Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc., and…
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 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 May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab). AbbVie’s first action was brought in the Northern District of Illinois on April 27, 2021. We previously…
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…
Last week, Vizient, a healthcare performance improvement company, released its Summer 2020 Drug Price Forecast. In the forecast, Vizient reported on the role of COVID-19 in changing healthcare priorities and affecting spending. Particularly, it advised its member health care groups to hedge against drug price inflation, which it estimated will…