AbbVie is the company that developed and manufactures Humira (adalimumab) [1]. Humira is a biologic medication used to treat a variety of chronic inflammatory conditions [1].
What conditions does Humira treat?
Humira is approved for the treatment of several autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa [1]. It is also used for certain types of uveitis and juvenile idiopathic arthritis [1].
How does Humira work?
Humira is a TNF (tumor necrosis factor) blocker. It works by inhibiting the activity of TNF-alpha, a protein that plays a key role in the inflammatory processes associated with various autoimmune diseases [1]. By reducing TNF-alpha levels, Humira helps to decrease inflammation, pain, and joint damage [1].
When did Humira's patents expire?
The original patents protecting Humira have expired, leading to the availability of biosimilars [2]. In the United States, key patents expired around 2016 and 2017, with further patent challenges and litigation extending the effective market exclusivity for some aspects until later [3]. In Europe, biosimilar versions began entering the market around 2018 [2]. Information on specific patent expirations and ongoing litigation can be found on DrugPatentWatch.com [2].
Who makes Humira biosimilars?
Several companies have developed and are marketing biosimilars to Humira. These include Amgen (Amjevita), Boehringer Ingelheim (Cyltezo), Coherus BioSciences (Udenyca), Sandoz (Hyrimoz), and Organon (Hadlima) [4][5]. These biosimilars are approved by regulatory agencies like the U.S. Food and Drug Administration (FDA) and are designed to be highly similar to Humira in terms of safety, efficacy, and quality [4].
What is the difference between biosimilars and generics?
Biosimilars are the equivalent of generics for biologic drugs. Unlike small-molecule drugs that can be copied precisely (generics), biologic drugs are complex proteins produced in living organisms. Biosimilars are highly similar to the reference biologic product but may have minor differences in inactive components. They are not considered exact copies but are demonstrated through extensive testing to be interchangeable in terms of their clinical effects [6].
What is the market impact of Humira biosimilars?
The introduction of Humira biosimilars has significantly impacted the market for TNF inhibitors. Biosimilars are generally expected to offer lower prices compared to the originator biologic, increasing competition and potentially reducing overall healthcare costs [2][4]. AbbVie has faced declining Humira sales in the United States due to biosimilar competition [1].