On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab). This approval enables Celltrion to launch two additional autoinjector formulations (45mg/0.5mL and 90mg/1.0mL) in Canada.
Canada has seen significant biosimilar activity for ustekinumab. The following products have already been approved by Health Canada:
| Biosimilar | Manufacturer | Health Canada Approval | Launch |
|---|---|---|---|
| Jamteki | JAMP Pharma / Alvotech | November 2023 | March 2024 |
| Wezlana | Amgen | December 2023 | March 2024 |
| Steqeyma | Celltrion | July 2024 | August 2024 |
| Pyzchiva | Samsung Bioepis | August 2024 | Not yet launched as of reporting |
| Otulfi (FYB202) | Formycon / Fresenius Kabi | 8 January 2025 | May 2025 |
| Yesintek | Biocon Biologics | 17 October 2025 | Mid-October 2025 |
| Imuldosa | Dong-A ST / Intas | January 2026 | Not yet launched in Canada |
The US market has seen an even bigger wave of ustekinumab biosimilar activity in 2025. By the end of the year, the FDA had approved a total of eight ustekinumab biosimilars. The following biosimilars launched in the US during 2025:
| Biosimilar | Manufacturer | US Launch Date | Interchangeable Status |
|---|---|---|---|
| Wezlana (ustekinumab-auub) | Amgen | January 2025 | Yes — first interchangeable ustekinumab biosimilar |
| Selarsdi (ustekinumab-aekn) | Alvotech / Teva | 21 February 2025 | Yes |
| Pyzchiva (ustekinumab-ttwe) | Samsung Bioepis / Sandoz | 24 February 2025 | Provisional — pending expiry of Wezlana’s 1-year interchangeability exclusivity |
| Yesintek (ustekinumab-kfce) | Biocon Biologics | February 2025 | No |
| Otulfi (ustekinumab-aauz) | Fresenius Kabi / Formycon | 3 March 2025 | Yes |
| Steqeyma (ustekinumab-stba) | Celltrion | 13 March 2025 | No |
| Imuldosa (ustekinumab-srlf) | Dong-A ST / Accord BioPharma | 18 August 2025 | No |
| Starjemza (ustekinumab-hmny) | Bio-Thera Solutions / Hikma | 6 November 2025 | Yes |