AbbVie and Amgen settle Humira clash

AbbVie and Amgen settle Humira clash

AbbVie announced today a global resolution of all intellectual property-related litigation with Amgen over Amgen's proposed biosimilar adalimumab product.

The settlement calls for AbbVie to grant Amgen a nonexclusive license to AbbVie's Humira-related intellectual property.

In August previous year, LSIPR reported that AbbVie had sued Amgen at the US District Court for the District of DE, saying that Amgen's proposed biosimilar infringes 61 patents.

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 agreement requires Amgen to pay royalties to AbbVie for sales of the biosimilar, according to the release.

The Humira settlement "adds unexpected royalties during the biosimilar years and indicates that AbbVie's patents. are defensible", BMO Capital Markets analyst Alex Arfaei said in a research note.

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A trial in the Amgen dispute, involving 10 patents, was scheduled for November 2019, in what could have been just the first wave of litigation between the two companies.

"Amgevita will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market", Scott Foraker, vp and general manager of biosimilars at Amgen, said in a company statement.

The settlement, which removes a major overhang for AbbVie given its dependence on Humira, sent its shares to an all-time high of $90.95 before settling back to $89.87, up 6 percent.

Biosimilars are meant to be less costly versions of expensive biotechnology medicines.

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. Amgen's willingness to drop its legal fight against AbbVie might make other companies reassess their own court battles, added Erik Gordon, a University of MI professor with an expertise in entrepreneurship and health care. AbbVie said the patent-license periods would begin on other dates in various countries. As a result, few so-called biosimilars have entered the US market, and those that have been cleared haven't done much to drive down prices.

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