AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.
Alvotech announced that it has entered into a settlement agreement with AbbVie that will allow Alvotech to market AVT02 (100 mg/mL), its high-concentration, citrate-free biosimilar adalimumab that references Humira, in the United States.
The settlement fully resolves all pending US disputes between the 2 companies related to the adalimumab biosimilar, including the International Trade Commission (ITC) case that was filed in December 2021, in which AbbVie alleged that Alvotech developed AVT02 through the theft of trade secrets. The agreement fully removes any corresponding litigation-related barriers keeping AVT02 from reaching US patients with rheumatic conditions.
Per the terms of the settlement, Alvotech will be allowed to market AVT02 beginning July 1, 2023, meaning that the biosimilar could become the second adalimumab biosimilar to enter the US market following Amgen’s Amjevita, which is expected to launch in January 2023. Organon and Samsung Bioepis’ Hadlima, Viatris and Fujifilm Kyowa Kirin’s Hulio and Coherus Biosciences’ Yusimry are also anticipated to launch in July 2023.
The results of several patent litigation cases with AbbVie have made it so that all biosimilars to Humira are not allowed to enter the market until 2023.
The news comes about a week after the Reykjavik, Iceland–based company announced that the FDA had accepted a biologics license application (BLA) for AVT02 to be approved with an interchangeability designation.
“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment….We view today as a key milestone for patients and for our mission to fight for healthcare sustainability,” said Robert Wessman, founder and chairman of Alvotech, in a company statement.
AVT02 has the potential to be the eighth adalimumab biosimilar to be approved by the FDA, as well as potentially the second adalimumab biosimilar to receive an interchangeability designation, following the low-concentration version of Cyltezo, which was approved as the second biosimilar to ever be approved for interchangeability in October 2021.
Interchangeable designations allow for biosimilar products to be automatically substituted in place of an originator at the pharmacy level without requiring physician permission. The only way for a company to obtain interchangeability for a biosimilar is to submit additional data, collected from a switching study involving multiple switches between the biosimilar and the reference product, to the FDA.
According to Alvotech, it is the only company that has both developed a high-concentration, citrate-free adalimumab biosimilar candidate and conducted a switching study intended to support interchangeability. Although high-concentration and low-concentration versions of Humira are currently on the US market, over 80% of prescriptions are for the high-concentration solution.
AVT02 has so far been approved for marketing in the European Union, Canada, and the United Kingdom. AVT02 was granted marketing authorization in the European Union in January 2022, where it will be marketed by STADA Arzneimittel under the names Libmyris and Hukyndra depending on the country. The biosimilar was approved by Health Canada in January 2022.
In September 2021, Alvotech announced that the FDA was deferring action on its BLA due to the COVID-19 pandemic impacting the ability for the agency to inspect the company’s manufacturing facility. Alvotech said that inspections have been scheduled to occur during the first and second quarters of 2022.
Alvotech resolves U.S. patent and trade secret disputes with AbbVie, securing U.S. rights for Alvotech’s proposed high-concentration biosimilar (AVT02) for Humira. News release. Alvotech Holdings; March 8, 2022. Accessed March 8, 2022. https://www.alvotech.com/newsroom/alvotech-resolves-u.s.-patent-and-trade-secret-disputes