FDA Approves Dong-A ST’s Imuldosa (Ustekinumab), a Stelara Biosimilar

Stelara now has a new biosimilar option on the market, as Dong-A ST’s Imuldosa (ustekinumab-srlf) has received approval from the US Food and Drug Administration (FDA) for the treatment of several autoimmune conditions. Imuldosa is indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, conditions that are also treated by its reference product, Stelara — a leading biologic therapy in the autoimmune space.

Imuldosa’s approval followed a rigorous review process by the FDA. Dong-A ST, in collaboration with Meiji Seika Pharma, initially began developing the drug in 2013. The rights were transferred to Dong-A ST for further development in 2020. Dong-A ST has partnered with Intas Pharmaceuticals, through its subsidiary Accord BioPharma, to commercialize the drug in the US.

Regulatory filings for Europe are also in progress, with a marketing authorization application submitted to the European Medicines Agency (EMA) in 2023. If approved, the biosimilar will be marketed in the European Union (EU).

Dong-A ST plans to expand Imuldosa’s global footprint, aiming to secure additional regulatory approvals. The company anticipates launching the biosimilar in other key markets, including the UK and Canada, to compete with Stelara, providing a more affordable option for patients with autoimmune conditions.

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Stelara Price Reductions and Expanding Biosimilar Competition

Imuldosa’s approval joins a wave of Stelara biosimilars. In October 2023, Amgen’s Wezlana (ustekinumab-auub) became an interchangeable biosimilar approved by the FDA, eligible for pharmacy-level substitution. Selarsdi (ustekinumab-aekn), developed by Alvotech and Teva, expands treatment to both adults and pediatric patients, with its US launch set for 2025. Sandoz followed with Pyzchiva (ustekinumab-ttwe), offering provisional interchangeability, and Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz) provides flexible dosing with both subcutaneous and intravenous (IV) options.

In the EU, Celltrion’s SteQeyma (CT-P43) was approved in August 2024, based on successful Phase III trial results in moderate to severe plaque psoriasis. Meanwhile, Bio-Thera Solutions, in collaboration with Gedeon Richter, is also preparing for the launch of their Stelara biosimilar, BAT2206, in the EU and other selected markets, with regulatory approval anticipated soon.

Meanwhile, under the Inflation Reduction Act (IRA), CMS announced a 66 percent price reduction for Stelara, effective in 2026. Although this aims to reduce out-of-pocket costs for Medicare patients, industry experts argue that these pricing moves could disrupt the anticipated competition from current Stelara biosimilars, potentially complicating and influencing market dynamics just as new biosimilars are about to launch.