Payday for AbbVie as Humira biosimilar delayed for five years

Amgen will not launch a biosimilar version of AbbVie’s Humira in the US until 2023, as part of a deal resolving litigation between the two companies.

Even though Amgen got its biosimilar approved by the FDA last year, it has not been able to launch in the US because of a network of patents set up by AbbVie.

Under terms of the settlement, AbbVie has granted Amgen a non-exclusive licence to intellectual property relating to Humira (adalimumab), beginning on 31 January 2023.

In Europe, the licence period will begin in October 2018 when the drug’s patent expires in most countries, and on other dates in various countries where AbbVie has intellectual property.

Amgen will pay royalties under the agreements, but further details remained confidential. All further litigation between the companies will be dismissed.

Humira is currently the world’s biggest-selling drug, generating $16 billion in revenues in 2016.

Before the settlement with Amgen, AbbVie had been predicting peak sales in the region of $20 billion, and the feeling is that this could still be achievable even with the biosimilar competition in the EU.

The deal is significant because the bulk of Humira’s sales are based in the US, where revenues were in the region of $10.4 billion last year.

A host of other companies are also attempting to market copies of Humira – in the US the FDA has already backed Boehringer Ingelheim’s biosimilar.

But Amgen – a pharma company that is well-known for its legal acumen – is clearly confident that its biosimilar competitors will also be unable to launch in the US until 2023, otherwise it would not have signed the agreement.

This has led to speculation that sales of Humira will continue to mount over the coming years in the US until the competitors become available.

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In Europe price competition is set to begin in earnest next year as Humira biosimilars from Amgen and Samsung Bioepis are already approved, and Boehringer Ingelheim’s contender will likely have a licence soon after backing from the CHMP regulatory committee.

A Humira biosimilar from Novartis’ generics and biosimilars arm Sandoz is also under review in Europe, and could be licensed around the time of patent expiry following a filing in May.