- Mylan has agreed to hold off bringing a version of AbbVie's Humira to the U.S. market until mid-2023 per the terms of a newly inked deal.
- In exchange for a non-exclusive license, Mylan will pay AbbVie royalties once it begins selling the Humira biosimilar. More importantly for AbbVie, however, is that the deal keeps another threat to its mega-blockbuster at bay — at least for several more years.
- Humira has long been AbbVie's top-selling product and continued that trend during the first quarter, during which net revenue for the drug hit $4.7 billion, or about 60% of the company's total net revenue. Rival companies, including Amgen, Boehringer Ingelheim and Samsung Bioepis, have tried to snag some of that cash with copycat products, but so far haven't brought any to market.
The licensing deal is good news for Mylan, better news for AbbVie. Though Humira (adalimumab) has been on the market for more than 15 years, it continues to be incredibly lucrative. Last year, it raked in $18.4 billion in sales for AbbVie and is expected to crest past $20 billion in 2018.
Naturally, that success hasn't gone unnoticed. In an investor note from September, Leerink counted at least nine Humira biosimilars either in development or cleared by the Food and Drug Administration. From its end, AbbVie has been dogged at fending off the copycats — jumping into legal battles with Amgen, Boehringer and Novartis, among others.
It's a strategy that has paid off too. Amgen, the first company to get U.S. approval for a Humira biosimilar, in the fall entered a settlement with AbbVie that gave the California-based drugmaker non-exclusive rights to market its drug, Amjevita (adalimumab-atto), in most European countries starting Oct. 16, 2018 and in the U.S. starting Jan. 31, 2023.
And in another win, AbbVie recently entered a similar licensing pact with Sampsung Bioepis that keeps the South Korean company from selling its Humira biosimilar in the U.S. until June 30, 2023.
The deals underscore that while Humira's patents aren't impenetrable, they do appear to be an exhaustive legal hurdle. It's a hurdle that should award AbbVie between $19 billion and $22.4 billion annually until 2023, according to Leerink estimates, after which Humira revenue will rapidly decline.
AbbVie will get a small taste of those bottom line threats later this year, when Amgen's biosimilar breaks into Europe.
"You would expect that the business will grow [in Europe] until the fourth quarter in the mid-single digit range ... and then you will start to see the impact of biosimilars," AbbVie CEO Richard Gonzalez said during a first quarter earnings call.
"A little harder to tell at this point exactly how that's going to go. We've modeled it and I think we have a pretty good idea of how that will progress and I think it will fall within the expectations that we have put forth. But we're going to need to see as it actually plays out and we watch what the biosimilars' launch strategies really look like," he added.