- In the seventh deal of its type, Pfizer has reached a license agreement with AbbVie, granting the pharma non-exclusive rights to sell its Humira biosimilar in the U.S. beginning in 2023 and resolving all litigation between the two companies.
- Per terms of the deal, Pfizer would be able to launch its biosimilar copy of AbbVie's drug in Europe as soon as it receives approval there.
- Pfizer said financial details were confidential and disclosed no further information on the settlement — mirroring the approach of other companies which have reached deals with AbbVie.
Settlement deals have come quickly for AbbVie, with the agreement with Pfizer following close on the heels of a deal with Momenta Pharmaceuticals which pushed a launch of that company's Humira (adalimumab) copy to November 2023.
AbbVie has fenced Humira, its top-selling drug, with a ring of patents in the U.S., which it's used to stave off copycats. Global sales of the drug rose by 9% year over year in the third quarter, despite the impact of four Humira biosimilars launching in Europe.
Now, Pfizer has become the seventh pharma to reach a settlement with AbbVie over Humira.
Settlement deals keep Humira biosimilars at bay in U.S.
|Drugmaker||Biosimilar approved in the U.S.?||Expected launch date|
|Amgen||Yes, Amjevita||Jan. 31|
|Samsung Bioepis||No||June 30|
|Fresenius Kabi||No||Sept. 30, 2023|
|Novartis Sandoz||Yes, Hyrimoz||Sept. 30, 2023|
|Momenta||No||Nov. 20, 2023|
|Pfizer||No||Nov. 20, 2023|
The rogue holdout, Boehringer Ingelheim , remains locked in an ongoing legal challenge. It has an approved Humira biosimilar, Cyltezo (adalimumab-adbm).
Boehringer recently confirmed to BioPharma Dive it has decided to pull out of biosimilar development in the rest of the world, focusing instead on the U.S. market.
"Our focus is on bringing Cyltezo to the U.S. market and we are committed to making it available to U.S. patients as soon as possible and certainly before 2023," a Boehringer spokesperson said in a statement to BioPharma Dive.