Fresenius Kabi Strikes Deal With AbbVie Over Humira

Fresenius Kabi has become the latest biosimilar developer to enter into an agreement with Humira maker AbbVie over a biosimilar adalimumab product, MSB11022.

Fresenius Kabi has not yet received approval for its biosimilar in the European Union or the United States, but the terms of the agreement will grant the biosimilar developer a nonexclusive license to sell its product in Europe immediately following authorization and in the United States beginning on September 30, 2023.

While the precise terms of the deal are not public, AbbVie’s announcement indicated that all pending litigation will be dismissed, and that Fresneius Kabi will pay royalties to AbbVie, but AbbVie will make no payments to Fresenius Kabi.

In its own statement, Fresenius Kabi indicated that it plans to launch MSB11022 in Europe during the first half of 2019, pending the European Union’s decision on its application for a marketing authorization that was submitted in December 2017.

“This agreement is a major step on our way to successfully developing and commercializing our biosimilar portfolio," said Michael Schönhofen, PhD, member of the Fresenius Kabi management board and president of the company’s pharmaceuticals division. “The agreement with AbbVie provides further clarity regarding when we will be able to commercialize our biosimilar candidate of Humira.”

This agreement closely mirrors those struck between AbbVie and a number of other biosimilar developers, though dates for US marketing vary slightly. A deal with Sandoz provides for a September 30, 2023, US launch of Hyrimoz; a settlement with Mylan allow for a US license term for Hulio to begin on July 31, 2023; a deal with Samsung Bioepis allows for US marketing of Imraldi on June 30, 2023; and a deal with Amgen allows for US marketing of Amjevita on January 31, 2023.

The only biosimilar developer with an EU- and US-approved biosimilar that has not announced such an agreement is Boehringer Ingelheim (BI), developer of Cyltezo. BI is also the only biosimilar developer to publicly announce that it is undertaking a clinical study to demonstrate the interchangeability of its product with Humira. If the FDA eventually grants Cyltezo interchangeable status, the product could be automatically substituted for Humira at the pharmacy level.