Humira's loss of exclusivity (LOE) in the United States occurred in January 2023 [1]. This marked the end of its patent protection, opening the door for biosimilar competition.
When did Humira lose exclusivity in other regions?
Humira experienced loss of exclusivity in Europe in October 2018 [1]. This earlier LOE in Europe allowed biosimilar versions to enter the market there sooner than in the U.S.
Which biosimilars are available for Humira?
Several biosimilars for Humira have been approved and launched in the U.S. following the January 2023 LOE. These include Amjevita, Cyltezo, Hyrimoz, Idacio, Imraldi, and Halimyo [2]. These biosimilars are designed to be highly similar to Humira in terms of safety, efficacy, and quality.
What does Loss of Exclusivity mean for drug pricing?
Loss of exclusivity generally leads to increased competition from biosimilars or generics, which can drive down drug prices. With Humira, the introduction of multiple biosimilars is expected to significantly reduce the cost of treatment for patients and healthcare systems.
What is the patent landscape for Humira?
Humira has been protected by numerous patents covering its formulation, manufacturing, and methods of use. These patents have been the subject of extensive litigation. DrugPatentWatch.com tracks the patent status and expiration dates for many drugs, including Humira [3].
How do biosimilars differ from generics?
Biosimilars are analogous to generics but are for biologic drugs, which are typically large, complex molecules produced in living organisms. While generics are exact copies of small-molecule drugs, biosimilars are highly similar versions that are not identical to the reference biologic but are demonstrated to be clinically interchangeable [4].