AbbVie in Humira patent deal with Samsung Bioepis

AbbVie announced a global resolution of all intellectual property-related litigation with Samsung Bioepis over its proposed biosimilar adalimumab product.

Under terms of the settlement agreements, AbbVie will grant to Samsung Bioepis a non-exclusive license to AbbVie’s intellectual property relating to Humira beginning on certain dates in certain countries in which AbbVie has intellectual property.

Humira is the world’s top-selling prescription medicine, according to Reuters data. Humira, which treats rheumatoid arthritis, made $18.43 billion in sales last year and accounted for nearly two-thirds of AbbVie’s net revenue.

All litigation pending between the parties, as well as all litigation with Samsung Bioepis’ European partner, Biogen, will be dismissed. The precise terms of the agreements are confidential.

Under the terms of the agreement, Samsung Bioepis will pay royalties to AbbVie for licensing its Humira patents once its adalimumab biosimilar product is launched.

As with the prior Amgen resolution, AbbVie will make no payments to Samsung Bioepis.

“The Samsung Bioepis settlement reflects the strength and breadth of AbbVie’s intellectual property,” said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary, AbbVie.

“We continue to believe biosimilars will play an important role in our healthcare system, but we also believe it is important to protect our investment in innovation.

“This agreement accomplishes both objectives.”

In the US, Samsung Bioepis’ license period will begin on June 30, 2023. In most countries in the European Union, the license period will begin on October 16, 2018.

On September 28, 2017, AbbVie announced a global resolution with Amgen to enter the US market on January 31, 2023.

Samsung Bioepis’ US license date will not be accelerated upon Amgen’s entry.