Blog Big Molecule Watch February 08, 2022

International Trade Commission Institutes Investigation of Alvotech’s Adalimumab Biosimilar

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 Ivers-Lee AG alleging unfair competition under Section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337).  The complaint alleges misappropriation of trade secrets and tortious interference with contractual relations. AbbVie has requested an exclusion order prohibiting the importation into the United States of Alvotech’s pre-commercial adalimumab biosimilar named AVT02 (commercialized in Europe under the product names Libmyris and Hukyndra).

On January 31, the Commission’s Notice of Institution was published in the Federal Register indicating institution of the investigation.  The Investigation is designated as Investigation No. 337-TA-1296 and it has been assigned to Administrative Law Judge Bhattacharyya, who was named to the bench in September of last year.  The parties have been ordered to propose, among other things, a target date for the end of the investigation and a discovery schedule by February 25.

The post International Trade Commission Institutes Investigation of Alvotech’s Adalimumab Biosimilar appeared first on Big Molecule Watch.