A US$17.3bn Market
The sale of Humira biosimilars in the United States is scheduled to start next month. This market is expected to be as huge as US$17.3 billion. More than 10 global biopharmaceutical companies are focusing on it, including Amgen, Samsung Bioepis, and Celltrion. Samsung Bioepis' biosimilar will be commercialized by its partner Organon.
Amjevita, a Humira biosimilar from Amgen, is scheduled to be released on Jan. 31. The target months of Samsung Bioepis and Celltrion are July.
AbbVie developed Humira for autoimmune disease treatment. The global sales of the product amounted to US$20.7 billion last year, including more than 80 percent generated in the United States.
According to industry insiders, the impact of Amjevita is likely to be less than expected. “Humira in the market is divided into low- and high-concentration formulations, patients prefer the latter for less drug administration, and the latter accounted for 80 percent of Humira sold in the United States last year,” one of them said.
The third phase of the clinical trial of the high-concentration formulation of Amjevita is yet to be completed, while the U.S. FDA already approved the low-concentration formulation.
By contrast, both versions of Hadlima from Samsung Bioepis have been approved by the U.S. FDA. Hadlima is expected to be launched on or after July 1, 2023 by Organon, Samsung Bioepis' partner.
Yuflyma developed by Celltrion is a high-concentration formulation.