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Samsung Bioepis and Biogen secure licensing deal with Abbvie for Humira biosimilar

Published on 06/04/18 at 10:44am

Partners Biogen and Samsung Bioepis have secured the future of their Humira (adalimumab) biosimilar after penning a deal with Abbvie which grants patent licenses for the sale of the product in Europe and the US, and stipulates that the three parties agree to dismiss any ongoing litigation surrounding the issue.

The biosimilar was approved in Europe in August last year. Under the terms of the deal, the pair will be able to commercialise Imraldi in the continent as early as 16 October, but in the US they will have to wait until 30 June 2023 following the expiry of a key patent, which is good news for Abbvie, protecting its market share on the world’s biggest drug for a number of years in the region.

Abbvie’s drug, a treatment for rheumatoid arthritis, generated $18.43 billion for the company last year – two-thirds of its total sales – and two-thirds of the revenue generated by the therapy was made in the US. The company may have bought itself more time, but the treat of biosimilar competition, though distant, is still looming on the horizon, with products from rivals such as Boehringer Ingelheim and Novartis/Sandoz poised to cut into its share.

According to the agreement, marketing rights in Europe will be granted on a country-by-country basis, with Samsung Bioepis and Biogen agreeing to pay royalty payments to Abbvie, who itself will make no payments to the pair.

“The Samsung Bioepis settlement reflects the strength and breadth of AbbVie's intellectual property,” commented Laura Schumacher, AbbVie’s General Counsel.  “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.”

Matt Fellows

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