- AbbVie yet again demonstrated how strong the patent defenses are for its biggest brand, announcing Thursday an agreement with Novartis' Sandoz that will keep the Swiss pharma's Humira biosimilar from the U.S. market until late 2023.
- First approved in 2002, Humira has since become the world's top-selling drug. In the second quarter alone, AbbVie recorded nearly $5.2 billion in net revenue from the anti-inflammation biologic.
- Those incredible returns haven't gone unnoticed by rivals, however. Novartis, Amgen, Samsung Bioepis and others have developed Humira copycats, but none have been commercialized in the U.S. because of AbbVie's strong patent protections.
There are now deals in place with four of the main threats to AbbVie's U.S. Humira (adalimumab) franchise. A legal battle with Boehringer Ingelheim is ongoing, but assuming it goes in the Illinois-based pharma's way, Humira won't see stateside biosimilar competition until early 2023.
A handful of other drugmakers are also developing Humira biosimilars, although those projects are less advanced.
AbbVie's ability to ward off threats isn't an isolated instance, however. Biosimilars as a whole haven't drastically affected the U.S. pharmaceutical market due to patent litigation. It's a trend that has frustrated some drug companies as well as lawmakers, exemplified last month when the Senate passed a bill aimed at making settlements between makers of reference products and copycats more transparent.
Settlement deals keep Humira biosimilars at bay in US
|Competitor||Biosimilar Humira approved in US?||Entry date per settlement|
|Amgen||Yes, Amjevita||Jan. 31, 2023|
|Samsung Bioepis||No||Jun. 30, 2023|
|Mylan||No||Jul. 31, 2023|
|Novartis (Sandoz)||No||Sep. 30, 2023|
|Boehringer Ingelheim||Yes, Cyltezo||No settlement reached|
SOURCE: Company statements
In Europe, the pressures facing Humira are more immediate. There, the drug's composition of matter patent expires next week, thereby opening the door to five copycat versions already approved by the European Commission.
Though most Humira revenue comes from the U.S., Europe remains a substantial market too — accounting for more than a fifth of its sales from July 2017 to June 2018, according to Iqvia data cited by Reuters. As such, Wall Street will be eyeing Europe to see how much of a chunk biosimilars take out of AbbVie's bottom line.
"Certainly over the next couple of quarters we're going to be watching that very closely," said Credit Suisse analyst Vamil Divan in a recent interview with BioPharma Dive, adding that competition to Humira raises the stakes for AbbVie to deliver on its late-stage pipeline.
"They have Imbruvica and other products which are very successful products now, but they need the pipeline to come through," he said.
Similar to its agreements with Amgen, Samsung Bioepis and Mylan, AbbVie's deal with Sandoz grants the Novartis business a non-exclusive license to intellectual property related to Humira. The license kicks in on Sept. 30, 2023 in the U.S. "and will not be accelerated by the entry of companies who have already taken a license," according to an Oct. 11 statement.
Meanwhile, the license starts on Oct. 16, 2018 in most European Union countries, aligning with the date Humira's composition of matter patent expires.
"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. This agreement accomplishes both objectives," said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary at AbbVie, in the statement.