AbbVie now has all of its ducks in a row, after it agreed to a non-exclusive licensing deal with Boehringer Ingelheim, which allows the latter to bring its biosimilar to Humira (adalimumab) to the US market on July 1, 2023.
This last deal means that AbbVie has protection against any biosimilar competitors for its product until 2023, after making similar deals with eight other companies.
Boehringer was only the second company to receive US Food and Drug Administration approval and the first in the European Union (EU) for its version of Humira.
When it came to agreeing to a licensing deal with AbbVie, Boehringer was the last to do so – after its fight to bring its biosimilar, Cyltezo, to the US market ended up in court.
However, the litigation resulted in a judge finding in favour of AbbVie, which would have compelled Boehringer to disclose its US launch plans.
A spokesperson for Boehringer explained why it decided to drop the case, “We had hoped that litigation was going to make Cyltezo available sooner, however with the inherent unpredictability of litigation, the substantial costs of what would have been a long and complicated legal process and ongoing distraction to our business, we have concluded that this settlement is the best solution.”
AbbVie protects US market
If it had been successful in its litigation, Boehringer’s Cyltezo would have become the first biosimilar to enter a market worth $13.6bn (€11.9bn) in the US during 2018.
As it is, AbbVie will reap those sales instead, which will soften the blow of biosimilar competition to market share in the EU.
“This is an important settlement as it resolves all Humira-related patent litigation in the US and provides access for another biosimilar manufacturer seeking to enter the US,” said Laura Schumacher, chief legal officer at AbbVie.
AbbVie confirmed that it will make no payments to Boehringer as a result of the licensing agreement.