As the expiry of the U.S. patent of Humira, AbbVie’s autoimmune disease treatment, draws near, its biosimilar market stirs with expectations.

Clarivate, an information analysis company, said so in its “2023 Blockbuster New Drug Report,” released on Thursday.

The report predicted the expiry of Humira’s patent early this year would ignite competition among its biosimilar products in the United States.

There are seven Humira biosimilars from seven companies approved in the U.S. Amgen’s Amjevita will likely hit the market earliest, on Jan. 31, followed by three drugs to be released on July 1 – Hadlima of Organon and Samsung Bioepis, Cyltezo of Boehringer Ingelheim, and Yusimry of Coherus.

Four more biosimilars from four companies are also waiting for approval. Celltrion’s Yuflyma is one of them.

The report expected the market releases of Humira’s biosimilars to affect AbbVie’s revenue heavily. Humira accounted for 37 percent of AbbVie’s sales in 2021. Humira’s U.S. sales totaled $17.3 billion in 2021 but are expected to drop to $13.9 billion this year and $1.4 billion in 2028.

In global markets, including Europe, competition has already begun between Humira and its biosimilars.

Fifteen biosimilars from nine companies have won approval in Europe, and 14 from eight companies have already completed their market releases, including Hadlima of Samsung Bioepis with the name Imraldi.

Their releases in Europe have immediately affected Humira’s global sales. The first Humira biosimilar was released in Europe in October 2018, but Humira’s global sales tumbled 31.1 percent in 2019. Moreover, sales continued to fall in 2020 by 7 percent, and in 2021, by 9.6 percent.

The report noted the slowing decline of Humira sales between 2019 and 2020 due to AbbVie’s price cut of Humira, forcing companies that had prepared to put its biosimilars to market to abandon or postpone their market releases.

Copyright © KBR Unauthorized reproduction, redistribution prohibited