AbbVie Reaches Settlement With Amgen Over Amgevita

Drug maker Amgen announced today that it has reached a global settlement with AbbVie, developer of reference adalimumab (Humira), over Amgen’s biosimilar adalimumab, Amgevita.

Under the agreement, AbbVie will grant patent licenses to Amgen for the sale of its drug on a country-by-country basis. As part of the settlement, the companies have dismissed all pending litigation over the drug.

Neither company disclosed the financial terms of the agreement, but Amgen indicated that it will launch its drug, to be marketed as Amgevita, in the European Union on October 16, 2018. In the United States, the biosimilar will be marketed under a slightly different name—Amjevita—and will launch on January 31, 2023.

"We look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide. [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 FDA approved Amgen’s biosimilar drug in September 2016, and the European Commission authorized its marketing in March 2017. However, litigation over AbbVie’s patents for the innovator Humira had made it unclear when the biosimilar would become commercially available. AbbVie had sued Amgen for infringing on 10 of its patents covering adalimumab.

News of today’s settlement raises questions as to whether a similar agreement could be forthcoming for AbbVie and Boehringer Ingelheim (BI), which saw its own biosimilar adalimumab, Cyltezo, approved by the FDA in August and recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this month.

In Cyltezo’s case, AbbVie filed an even more extensive lawsuit against BI, saying that BI would infringe on 74 patents. The first phase of BPCIA litigation over Cyltezo’s alleged infringement will involve 8 of those patents, as BI did not consent to AbbVie’s proposal of a single wave of patent litigation.

The reference Humira is the top selling drug in the world, earning AbbVie $16.08 billion in 2016. While its global sales grew by 14.7% last year, biosimilar competition and the introduction of new drugs are expected to erode its dominance in the rheumatoid arthritis and inflammatory disease marketplace.