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.

Boehringer is however on course to beat Mylan’s Hulio and Sandoz’s Hyrimoz to market, as these are due to make their US debuts on 31 July and 30 September 2023, respectively.

“This is an important settlement as it resolves all Humira-related patent litigation in the US,” said AbbVie’s chief legal officer Laura Schumacher in a statement.

AbbVie has been working hard to diversify beyond Humira, but the sheer size of Humira makes that a tough task. Newer products such as blood cancer drug Imbruvica (ibrutinib) – which brought in almost $3 billion last year – and hepatitis C virus therapy Mavyret ($1.6 billion) need to be joined by some more big sellers to close the gap.

In that regard, AbbVie is hoping for big things from its recently-approved Skyrizi (risankizumab) for psoriasis and late-stage JAK inhibitor upadacitinib for rheumatoid arthritis.

While it still has its sights set firmly on developing biosimilars for the US market, Boehringer has been stepping down its involvement elsewhere, and decided last year that it would not launch Cyltezo in Europe despite it already being approved for marketing by the EMA.