AbbVie returns to court to try to block Alvotech’s biosimilar candidate Adalimumab

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After seeing his adalimumab (Humira) trade secrets case against Alvotech dismissed by a court of law for incompetence, AbbVie again tries to file a case with the United States International Trade Commission (ITC).

AbbVie maintains that Alvotech’s biosimilar candidate for adalimumab (AVT02), which has yet to receive US FDA approval, was developed with solemn trade secrets by employees who previously worked for AbbVie and then went to work for Alvotech.

“AVT02 will significantly undermine Humira on pricing and unfair competition, resulting in lower revenues, lower profits, reduced return on investment and, therefore, material injury to the industry in which AbbVie has made a significant investment to maintain itself. develop in the United States, ”AbbVie wrote in the complaint. The ITC has the power to investigate and rule on alleged acts of counterfeit products.

Alvotech has previously declared that it is innocent of any taking or unlawful use of AbbVie’s trade secrets relating to the manufacture of adalimumab.

Theft allegations

The employees AbbVie claims to have stolen manufacturing information are Rongzan Ho, Yi Li Tan, and Zhi Sheng Sheah. All three began working with Alvotech after quitting AbbVie, according to the manufacturer. AbbVie alleges that Ho, Tan and Seah “were involved in setting up AbbVie’s Humira manufacturing plant in Singapore from scratch” and thus familiarized themselves with the company’s secret processes for manufacturing adalimumab.

“These employees not only learned and had access to documents describing
AbbVie know-how for managing a high quality manufacturing process for commercial scale production of adalimumab, but also learned and had access to documents describing AbbVie’s know-how to put Online a new adalimumab facility and get GMP certification for a new adalimumab facility, ”the AbbVie complaint mentioned.

In October 2021, Judge Harry D. Leinenweber of the U.S. District Court for the Northern District of Illinois declined to rule on the case because the alleged theft of trade secrets occurred overseas. Ho, for example, was based in Singapore and was working at an AbbVie facility there when he allegedly took secrets, quit, and went to work for Alvotech in Iceland. AbbVie claims to have interviewed Alvotech in late 2017 and started working there in January 2018.

AbbVie claims to have documented several attempts, including one successful, by Ho to send large Excel spreadsheets containing information about AbbVie’s confidential manufacturing processes to his personal email address. “With these documents, a competitor would have the know-how to manufacture an adalimumab-based drug substance,” AbbVie wrote.

Ho did not respond to a request for comment from the Center for Biosimilars®.

According to AbbVie, Ho was contacted about the alleged theft and admitted to taking the Excel information in a statement that was included on the ITC file but fully redacted from public access. Ho’s current curriculum vitae was also included in the documents and indicates that he worked for Alvotech for 2 years and 5 months and then went to work for Merck Life Science in Shanghai, China.

The case is significant for Abbvie as Alvotech plans to market an increasingly popular form of adalimumab (high strength, citrate free) in the United States and could potentially bring it to market sooner than other biosimilar competitors. There is no competition from adalimumab in the United States market to date.

“Alvotech … continues to publicly state that it will manufacture, import and market through Alvotech’s business partner Teva AVT02 manufactured in Iceland and in foreign jurisdictions and imported into the United States,” Alvotech wrote in the complaint. ‘ITC.

As part of its application for AVT02 approval with the FDA, Alvotech “imported” AVT02 into the United States, according to AbbVie, although some manufacture of a competitor’s product is permitted in an effort to develop a product rather than selling it.

The FDA began its review of AVT02 in November 2020 and has delayed an approval decision so it can complete inspections of manufacturing facilities. In November 2021, Alvotech received approval from the European Commission to market AVT02 under the product names Libmyris and Hukyndra.

AbbVie called on the ITC to open an immediate investigation into the alleged trade secret theft and to ban Alvotech from importing or selling AVT02 in the United States.

Alvotech and AbbVie disagree on AVT02 in a separate legal forum. The District Court for the Northern District of Illinois has heard a patent infringement dispute between the two companies, which is expected to be resolved in October 2022, if the proceedings proceed according to the court’s scheduling order.


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