The ustekinumab shift: biosimilars displace Stelara’s market leadership

Global Stelara sales dropped 14.7% year-over-year to roughly US$2.3 billion in 2024’s fourth quarter. For the full 12-month earnings period, Stelara sales slipped around 4.6% to US$10.4 billion. This decline marks the beginning of a seismic shift in the market, driven by biosimilars from players like Alvotech, Amgen, Biocon, and Samsung Bioepis.

The First Movers and the Race to Market
Amgen’s Wezlana made history as the first ustekinumab biosimilar with interchangeable designation approved in the US on 23 October 2023 [1], setting the stage for a wave of competitors. In Europe, Alvotech and STADA’s Uzpruvo is the first ustekinumab biosimilar approved on 5 January 2024 [3]. These first movers have a critical advantage: early market penetration and the opportunity to establish trust among healthcare providers and patients.

Since the approvals of Wezlana and Uzpruvo in the US and Europe in 2023 and 2024, respectively, the European Commission (EC) and US Food and Drug Administration (FDA) each has approved six more ustekinumab biosimilars. Additionally, Biocon’s Yesintek has received a positive opinion from CHMP and is pending for EC approval, bringing the total number of ustekinumab biosimilars competing in Europe and the US to 15. Table 1 lists these biosimilars, their authorization dates and launch status in Europe and the US.

A new era for autoimmune treatment
Analysts predict that Stelara’s market share will continue to erode as biosimilars gain approval and adoption. The biosimilar wave is not just about price competition—it’s about reshaping the treatment landscape for millions of patients with psoriasis, Crohn’s disease, and ulcerative colitis. Biosimilars make these life-changing therapies more accessible and affordable.

Upcoming ustekinumab biosimilars
The pipeline for ustekinumab biosimilars remains robust. Formycon’s FYB202 is pending for FDA approval, while Bio-Thera’s BAT2206 and BioFactura/CuraTeQ’s BFI-751 are in clinical trials. If approved, these candidates will bring the total number of ustekinumab biosimilars to 18, mirroring the competitive landscape of adalimumab biosimilars. This influx is expected to further intensify competition, driving down prices and improving patient access.

Currently, the originator biological Humira is the only product with 18 adalimumab biosimilars approved in Europe (8) and the US (10). Meanwhile, Stelara has 15 approved ustekinumab biosimilars, making ustekinumab the second most competitive biosimilar market, following adalimumab.