The launch dates for biosimilar versions of Humira (adalimumab) vary by region, with several having already entered the market in different countries.
When did Humira biosimilars first become available in the US?
In the United States, the first Humira biosimil, Amjevita, manufactured by Amgen, received FDA approval in September 2016. However, its market launch was delayed due to patent litigation with AbbVie, the manufacturer of Humira. Amgen and AbbVie reached a settlement, allowing Amgen to launch Amjevita in the US in January 2023 [1].
Which other Humira biosimil launches have occurred in the US?
Following Amjevita's launch, several other Humira biosimil manufacturers also made their products available in the US in 2023. These include Cyltezo (Boehringer Ingelheim), Hyrimoz (Sandoz), and Hadlima (Samsung Bioepis) [1][2]. Each of these biosimilars received FDA approval prior to their 2023 market entry.
When did biosimilar versions of Humira launch in Europe?
European markets saw earlier launches of Humira biosimilars. For instance, Amgevita from Amgen received European marketing authorization in March 2017, and subsequent biosimil versions from companies like Sandoz and Boehringer Ingelheim also became available in various European countries around the same period and shortly after [3].
What is the patent situation for Humira?
Humira has been protected by numerous patents held by AbbVie. These patents cover various aspects of the drug, including its formulation, method of use, and manufacturing processes. The expiry of these patents has been a key factor in enabling biosimilar competition [4]. Information on specific patent expiry dates and ongoing litigation can be found at DrugPatentWatch.com [4].
What is the significance of Humira biosimilar launches?
The introduction of Humira biosimilars is significant because Humira has been one of the world's best-selling drugs. Biosimilars offer a lower-cost alternative to the originator biologic, potentially increasing patient access and reducing healthcare expenditures. The competition from biosimilars can also drive innovation among biologic manufacturers [5].