Boehringer settles Humira lawsuit, joins biosimilar queue in US

Boehringer Ingelheim was the last man standing among challengers to AbbVie’s patents on immunology blockbuster Humira but has joined the pack and settled its litigation. The German company has agreed to delay the introduction of its Humira (adalimumab) biosimilar Cyltezo until 2023, following the example of Amgen, Merck & Co/Samsung Bioepis, Mylan/Fujifilm and Novartis’ Sandoz unit. AbbVie now has breathing space in the US to try to reduce its over-reliance on Humira, which brought in almost $20 billion in sales last year to account for nearly two-thirds of its total turnover in the year. It says the settlement with Boehringer doesn’t involve any payments “of any form”, and that Boehringer will pay royalties to AbbVie for licensing its patents. Humira grew 7% in the US last year, mainly due to price increases, but the product felt the effects of biosimilar competition in the smaller European market, where sales operationally fell 23% after patent protection expired last November, from a height of around $4.5 billion. The settlement means that Boehringer will not launch Cyltezo until 1 July 2023, which means it will reach the market after Amgen’s biosimilar Amjevita – due for launch on 31 January of that year, and a day after Merck/Samsung’s SB5 version, which is still awaiting FDA approval.