Dive Brief:
- AbbVie and Fresenius Kabi have signed a settlement and license agreement, settling all pending patent litigations between the two companies
- The agreement means that, dependent on marketing authorization, Fresenius Kabi can launch its adalimumab biosimilar in the U.S. after Sept. 30, 2023. The copycat biologic isn't yet submitted to or approved by the Food and Drug Administration.
- Fresenius Kabi filed a marketing authorization application for the drug in Europe late last year, and is aiming for launch there in the first half of 2019, as patent expiry opened the European Humira biosimilar market in mid-October.
Dive Insight:
Humira, the first fully human monoclonal antibody approved by the FDA, hit the U.S. market in 2003 as a treatment of rheumatoid arthritis. It has since picked up indications for psoriatic arthritis, ankylosing spondylitis, Crohn's disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis.
In 2017, Humira sales were $12.4 billion in the U.S. and $18.4 billion worldwide, making it the top-selling drug in the world and by far the most key product to AbbVie's bottom line. As such, biosimilar competition could cause significant hiccups to the company's revenue stream.
AbbVie has mostly stemmed competition through its extensive patent protection around Humira. And as the deal with Fresenius illustrates, AbbVie is willing to pull out these tools even when the AbbVie copycat has yet to gain approval.
For Fresenius, however, the deal means the company won't have to go continue an expensive and lengthy legal battle.
Earlier this month, AbbVie announced an agreement with Novartis' Sandoz to hold off launch of its biosimilar GP2017. The Sandoz drug has already secured approved in Europe as Hyrimoz and launched earlier this week.
Hyrimoz is one of the first Humira biosimilars to reach the European market, and analysts have said they'll be watching carefully to see how impactful this and other copycats will be on Humira's sales.
AbbVie also has settlements with Amgen, Samsung Bioepis, and Mylan and has not yet reached a settlement against Boehringer Ingelheim.
According to the Generics and Biosimilars Initiative, there are other biosimilars to Humira in the global pipeline, including from manufacturers Shire, Oncobiologics, Celltrion, Momenta Pharmaceuticals, and Coherus Biosciences.