Key trends to watch

The impending loss of
exclusivity of HUMIRA

HUMIRA sales could feel the impact of competition from
biosimilar versions of other products

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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).

Actual and forecast sales of HUMIRA globally, 2017-2028

Adalimumab biosimilars approved by the European Commission, by date of E.U. approval

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SOLYMBIC March 22, 2017 Amgen Europe BV N/A Withdrawn June 15, 2018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Cyltezo® November 10, 2017 Boehringer Ingelheim Cytelzo Withdrawn January 15, 2019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Halimatoz July 26, 2018 Sandoz N/A Withdrawn December 18, 2020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Kromeya April 2, 2019 Fresenius Kabi N/A Withdrawn December 17, 2019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

Source: BioWorld

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