Samsung Bioepis gains Japanese approval for intravenous Stelara biosimilar
- nuaxia
- 5 days ago
- 1 min read
Samsung Bioepis has received Japanese marketing approval for a 130mg intravenous formulation of its ustekinumab biosimilar referencing Stelara.
The newly approved intravenous formulation is indicated as induction therapy for patients with moderate-to-severe active Crohn's disease where other treatments are ineffective.
The approval is Samsung Bioepis' second Japanese ustekinumab biosimilar approval through its partnership with NIPRO, following the previously approved 45mg subcutaneous syringe formulation.
Field | Content |
Alert Type | Approval |
Drug Name | Ustekinumab biosimilar |
Brand Name | Ustekinumab BS Intravenous Infusion 130mg NIPRO |
Company | Samsung Bioepis; NIPRO Corporation |
Reference Product | Stelara |
Regulatory Authority | Japanese regulatory authorities |
Approval Type | Marketing approval |
Indication | Induction therapy for moderate-to-severe active Crohn's disease where other treatments are ineffective |
Therapy Area(s) | Gastroenterology; inflammatory bowel disease |
Geography | Japan |
What Happened | Samsung Bioepis received Japanese marketing approval for the 130mg intravenous formulation of its ustekinumab biosimilar referencing Stelara. |
Why It Matters | The approval expands the available formulations of Samsung Bioepis' ustekinumab biosimilar in Japan and provides an intravenous induction option for eligible Crohn's disease patients. |
Supporting Context | The approval follows the earlier Japanese approval of the 45mg subcutaneous syringe formulation through Samsung Bioepis' partnership with NIPRO Corporation. |
Key Takeaway | Samsung Bioepis has expanded its Japanese ustekinumab biosimilar offering with approval of a 130mg intravenous induction formulation. |
What to Watch | Commercial rollout through NIPRO and adoption of the intravenous biosimilar in Japanese Crohn's disease treatment. |
Primary Source | Samsung Bioepis |
Relevant Date | 3 September 2026 |
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