Humira Patent Disputes between Novartis and Abbvie Settled

Abbvie granted Novartis a non-exclusive license to manufacture and sell a Humira biosimilar.

Humira (adalimumab) is the leading global prescription drug, garnering $5.19 billion in sales for Abbvie in the second quarter of 2018 alone. It is approved for the treatment of a number of different indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa and juvenile idiopathic arthritis.

Abbvie has been fighting to delay the introduction of biosimilars into the European and U.S. markets. In 2017, the company settled a patent dispute with Amgen, successfully delaying the launch of its Humira biosimilar until January 31, 2023.

Most recently, Abbvie settled its patent disputes with Novartis over that company’s Humira biosimilar. Sandoz (the generics business of Novartis) received marketing approval for its Humira biosimilar from the European Commission in July, 2018 and has also submitted its application to the U.S. Food and Drug Administration.

As part of the agreement, Abbvie granted Novartis non-exclusive rights to market its Humira biosimilar. Novartis can begin marketing the drug in Europe as of October 16, 2018, but not until September 30, 2023 in the United States. No details were provided on the royalties that Abbvie will receive from Novartis.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.