AbbVie wants USITC to investigate Alvotech over Humira ‘theft’
AbbVie seeks to block imports of Alvotech’s biosimilar Humira (adalimumab) into the US, claiming that the Icelandic company plundered former employees and used its trade secrets to develop the drug.
A complaint filed with the US International Trade Commission (ITC) on Friday requests that the agency launch a Section 337 investigation AbbVie’s nordic competitor.
According to the complaint, a handful of other pharmaceutical companies including Amgen, Boehringer Ingelheim, and Pfizer have also received approval to produce their own adalimumab biosimilars and have negotiated patent licences with AbbVie.
The first of these licences will launch in the US market beginning January 31, 2023.
However, AbbVie claims that Alvotech’s ‘AVT02’ biosimilar is being manufactured using a process developed with trade secrets “stolen” from AbbVie.
“AVT02 will undercut HUMIRA significantly on price and unfairly compete, leading to lower revenue, lower profits, reduced return on investment and, as a result, significant injury to the industry,” the complaint claims.
Alvotech allegedly hired several high-profile employees knowledgeable of AbbVie’s Humira manufacturing process and other related secrets. Those employees then resigned from AbbVie and concealed their new employer and the product they would be working on.
Specifically, the complaint highlights Rongzan Ho, a former employee that AbbVie says took confidential documents describing the company’s “most secret and protected manufacturing processes”, and then went on to work at Alvotech.
The complaint said: “Alvotech’s purported development of its own adalimumab manufacturing process implausibly quickly for a company with zero experience with biologic manufacturing, confirm that the commercial-scale manufacturing process for AVT02 was developed with the benefit of access to AbbVie’s stolen trade secrets.”
AbbVie requests that the ITC institutes a limited exclusion order to prevent the biosimilar from being marketed in the US.
The complaint was filed on behalf of AbbVie by Finnegan partner Mareesa Frederik.
Pending litigation
In November 2020, Alvotech announced that its Biologics License Application for a biosimilar of AbbVie’s Humira and is currently waiting for final approval from the Food and Drug Administration (FDA) before launching.
The launch is also pending ongoing patent litigation between AbbVie and Alvotech in the US District Court for the Northern District of Illinois which is expected to conclude no later than October 2022.
In October, the Illinois court dismissed a separate lawsuit from AbbVie concerning the trade secret theft allegations.
Róbert Wessman, founder and chairman of Alvotech said: “Alvotech’s mission is to bring affordable medicines to market as soon as we can. Meritless accusations aimed at denying access to affordable medicines will not deter us from our mission and today serves as an affirmation of our efforts.”
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
