Court Settlement Delays Amgen’s Humira Biosimilar for Five Years in U.S.

Medication can launch in Europe a year from now

The settlement of a court battle means that the launch of Amgen’s biosimilar version of adalimumab (Humira, AbbVie) will be delayed in the United States by more than five years.

The two companies announced that they have reached a global settlement to resolve all pending litigation regarding the Amgen biosimilar, known as Amjevita in the U.S. and as Amgevita in some other nations. Under terms of the agreement, AbbVie will grant nonexclusive patent licenses for the use and sale of Amgevita/Amjevita worldwide, on a country-by-country basis, and the companies have agreed to dismiss all pending litigation.

Amgen expects to launch Amgevita in Europe on October 16, 2018, and Amjevita in the United States on January 31, 2023. AbbVie said the patent-license periods would begin on other dates in various countries. 

“Amgevita will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market," said Scott Foraker, vice president and general manager of Biosimilars at Amgen.

The settlement with Amgen “respects the breadth and strength of our intellectual property portfolio," said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary for AbbVie. 

Specific financial terms of the agreement were not disclosed.

On September 23, 2016, the FDA approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases, including moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis.

The FDA approved a second biosimilar to Humira, adalimumab-adbm (Cyltezo, Boehringer Ingelheim), in August 2017. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie.

Sources: Amgen and AbbVie; September 28, 2017; FDA; September 23, 2016; Boehringer Ingelheim; August 29, 2017.