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Settlement clears path for Biogen, Samsung’s Humira biosimilar

Biogen and partner Samsung Bioepis have agreed a deal that will allow their biosimilar version of AbbVie’s Humira to launch in Europe and the US.

The three companies have reached a settlement in patent litigation that sets out definitive launch dates for the new Imraldi biosimilar, which was approved by the EMA last August, on both sides of the Atlantic.

Europe is first in line for the new biosimilar with a launch now possible on 16 October, but Biogen and Samsung Bioepsis will have to wait until 30 June 2023 before they can commercialise the drug in the US - after the expiry of a key AbbVie patent on Humira (adalimumab). Imraldi hasn’t yet been approved by the FDA.

A similar deal was signed between AbbVie and Amgen in 2017, suggesting AbbVie is on track to defend its US revenues for Humira for around five years, which is a massive boost as the company currently makes almost two-thirds of its revenues from the immunology blockbuster. Moreover, two-thirds of Humira’s $18bn net revenues last year were made in the US market.

Amgen’s agreement was slightly different in that US sales of its Amjevita biosimilar can start from January 31, and both deals include royalty payments to AbbVie, although the details of those are being kept under wraps.

“The Samsung Bioepis settlement reflects the strength and breadth of AbbVie's intellectual property,” said 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.”

The start of biosimilar competition in Europe later this year puts around $4bn of Humira’s turnover at risk, but the settlements are seen as a victory for the company, ceding that market in order to reinforce the greater prize of longer US exclusivity.

It’s not the end of the matter entirely, as other Humira biosimilars are coming through development, including Boehringer Ingelheim’s Cyltezo which has been approved in the US and Novartis/Sandoz’ version which has been filed in Europe. Two agreements in hand reinforce 2023 as the threshold date for Humira biosimilars in the US however - giving AbbVie a little more time to reduce its reliance on its cash cow.

The company has made strenuous efforts to diversify into areas such as cancer, and has high hopes for new launches such as blood cancer therapies Imbruvica (ibrutinib) and Venclexta (venetoclax).

6th April 2018


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