All eyes will be on the expiry of a key U.S. patent covering AbbVie’s HUMIRA® (adalimumab) in 2023, which could see HUMIRA biosimilars launching in the United States throughout the year.
Although the company still holds some essential manufacturing patents that are not due to expire until 2034, with HUMIRA accounting for around 37% of AbbVie’s 2021 sales, the entry of adalimumab biosimilars is expected to have an impact on the company’s financials. It is estimated that HUMIRA sales in the United States could decline from $17.3 billion in 2021 to $13.9 billion in 2023 and $1.4 billion in 2028.
In international markets, AbbVie has already faced direct biosimilar competition for HUMIRA in Europe and other regions and countries. In the European Union, HUMIRA biosimilars were launched in October 2018 and had an immediate impact on international sales, which declined 31.1% in 2019, 7% in 2020 and 9.6% in 2021. This was due to AbbVie heavily discounting HUMIRA in response to biosimilar competition, prompting many companies to delay or abandon plans to launch adalimumab biosimilars in European markets.
HUMIRA sales could also feel the impact of competition from biosimilar versions of other products such as REMICADE® (infliximab) and Enbrel® (etanercept).
|Drug||EU approval||Authorization holder||U.S. product name||Status|
|AMGEVITA™||March 21, 2017||Amgen Europe BV||AMJEVITA™||Launched October 16, 2018|
|SOLYMBIC||March 22, 2017||Amgen Europe BV||N/A||Withdrawn June 15, 2018|
|IMRALDI™||August 24, 2017||Samsung Bioepis||HADLIMA™||Launched October 17, 2018|
|Cyltezo®||November 10, 2017||Boehringer Ingelheim||Cytelzo||Withdrawn January 15, 2019|
|Hyrimoz®||July 26, 2018||Sandoz||Hyrimoz||Launched October 16, 2018|
|Hefiya||July 26, 2018||Sandoz||N/A||Launched October 16, 2018|
|Halimatoz||July 26, 2018||Sandoz||N/A||Withdrawn December 18, 2020|
|HULIO™||September 17, 2018||Viatris Inc||Hulio||Launched October 19, 2018|
|IDACIO®||April 2, 2019||Fresenius Kabi||N/A||Launched May 3, 2019|
|Kromeya||April 2, 2019||Fresenius Kabi||N/A||Withdrawn December 17, 2019|
|Amsparity||February 13, 2020||Pfizer Inc||Abrilada||Launch delayed|
|Yuflyma®||February 11, 2021||Celltrion||N/A||Launched June 23, 2022|
|LIBMYRIS||November 12, 2021||STADA Arzneimittel AG||N/A||Launched June 9, 2022|
|HUKYNDRA||November 15, 2021||STADA Arzneimittel AG||N/A||Launched June 9, 2022|