Coherus Settles With AbbVie, Sues Amgen, Over Biosimilar Adalimumab

Coherus BioSciences announced on Friday that it has become the latest biosimilar developer to settle with AbbVie, maker of the brand-name adalimumab, Humira, over a proposed biosimilar.

The settlement resolves global patent disputes between the 2 companies over CHS-1420, Coherus’ proposed adalimumab biosimilar that has yet to receive regulatory approval in either the United States or the European Union.

While the details of the settlement were not disclosed by either company, Coherus did acknowledge that it would pay royalties to AbbVie on the sale of its biosimilar, and that the product, once approved, will be able to launch in the United States on December 15, 2023.

In striking a deal with AbbVie, Coherus has followed in a long line of developers who have made similar agreements; Pfizer, Amgen, Mylan, Samsung Bioepis, Sandoz, Fresenius Kabi, and Momenta have all reached deals with the Humira maker, with terms that ensure that no biosimilar product will enter the US market prior to January 2023. Only 1 biosimilar developer with an approved adalimumab biosimilar, Boehringer Ingelheim, has signaled that it will forego a settlement in favor of continued litigation.

In an intellectual property (IP) twist concerning its biosimilar product, Coherus also announced on Friday that it has sued rival biosimilar developer, Amgen.

In a complaint filed in the United States District Court of Delaware, Coherus alleged that Amgen’s biosimilar adalimumab, approved in the United States as Amjevita and in the European Union under the slightly different name Amgevita, infringes on 3 patents held by Coherus. The patents, 10,155,039, 10,159,732, and 10,159,733, are directed to stable formulations of adalimumab.

According to Coherus’ complaint, the manufacture of the EU-marketed Amgevita in the United States constitutes infringement on the 3 US patents, and warrants an award of damages. Coherus has also asked the court to bar Amgen from infringing on these patents in the future.

In a statement, Coherus’ chief executive officer and president, Dennis Lanfear, said, “Coherus recognized early on the central role intellectual property would play in advancing biosimilars to market. One important element of our IP strategy for advancing our Humira biosimilar…is reflected in the success we’ve achieved in patenting our innovations in the field of adalimumab formulation. We believe in the strength of our IP and we intend to protect it.”

While lengthy and costly patent disputes between reference product sponsors and biosimilar developers are a familiar part of the US biosimilar landscape, Coherus’ suit against Amgen could signal a move into new territory; there have been, to date, no similar US suits filed between developers of biosimilar products of the same reference biologic.