Biosimilars, Legal

$21B or bust! AbbVie ensures its blockbuster US marathon on Humira will run into 2023

AbbVie has finished another big section in its great wall of protective IP deals that will keep the world’s biggest blockbuster unmarked by biosimilar competition in the US for 5 long years.

Laura Schumacher

Six months after AbbVie struck a deal with Amgen that allows a knockoff of Humira to hit US shores on January 31, 2023, Samsung Bioepis and Merck signed off on an agreement to unveil their biosimilar on June 30, 2023. In most countries in the EU, though, the debut will come this fall, on October 16.

“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,” noted AbbVie EVP and general counsel Laura Schumacher. “This agreement accomplishes both objectives.”

How important is this for AbbVie?

The biopharma company has been fighting for time to get new drugs lined up for the market so it can replace a drug that provides the lion’s share of its revenue. AbbVie earned more than $18 billion from Humira last year, with the revenue rising steadily as it continues to push through annual hikes in the price.

Richard Gonzalez

In its Q3 report last year the company reported that it now expects to see Humira sales climb to close to $21 billion in 2020. To put that in some perspective, CEO Rick Gonzalez had forecast peak sales at $18 billion by 2020 less than two years ago. That $3 billion in extra sales represents the kind of blockbuster revenue most biopharmas would be happy to see from any one of its drugs. And most of it was delivered by controversial price increases.

The deal comes as US officials are working on a plan to strip away some of the defensive moves that big players like J&J have used to keep biosimilar competition at bay. That’s another threat that AbbVie won’t have to fret about.


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