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Other Disclosures4554Fuji Pharma Co.,Ltd.Pharmaceuticals

Notice of Approval to Manufacture and Market “Ustekinumab BS Intravenous Infusion 130 mg ‘F’” — Expanding the Ustekinumab BS Product Range

Fuji Pharma Co., Ltd. has obtained marketing approval for the biosimilar “Ustekinumab BS IV Infusion 130 mg ‘F’,” used for induction therapy in Crohn’s disease. The company is targeting NHI drug price listing and a launch in November 2026, expanding its product lineup for the same active ingredient alongside its existing subcutaneous injection products.

Worth reading
41Recurring
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Improvement
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Announced details

Ustekinumab BS IV Infusion 130 mg “F”Ustekinumab BS Subcutaneous Injection 45 mg Syringe “F”Ustekinumab BS subcutaneous injection 90 mg syringe “F”
Applicable field (uses covered by this announcement)

Induction therapy for moderate to severe active Crohn’s disease (limited to cases in which existing treatment has been inadequately effective)

Launch dateTargeting NHI drug price listing and a launch in November 2026 (planned)
Impact on Business Performance

The disclosure states that future business performance and other factors may fluctuate for various reasons. No specific impact amount has been disclosed.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredUstekinumab BS IV Infusion 130 mg “F”, Ustekinumab BS Subcutaneous Injection 45 mg Syringe “F”, Ustekinumab BS subcutaneous injection 90 mg syringe “F”
Launch dateTargeting NHI drug price listing and a launch in November 2026 (planned)
Applicable areaInduction therapy for moderate to severe active Crohn’s disease (limited to cases in which existing treatment has been inadequately effective)
Impact on Business PerformanceThe disclosure states that future business performance and other factors may fluctuate for various reasons. No specific impact amount has been disclosed.
Items this document does not state (14)
CounterpartyCounterparty overviewRelationship with the CompanyContract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historySource

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To expand the ustekinumab biosimilar product lineup and establish a structure capable of providing treatment options ranging from induction therapy to maintenance therapy for Crohn’s disease. The company also aims to contribute to the wider adoption of biosimilars in the inflammatory bowel disease field and improve patient access to treatment.

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Notice of Approval to Manufacture and Market “Ustekinumab BS Intravenous Infusion 130 mg ‘F’” — Expanding the Ustekinumab BS Product Range | Fuji Pharma Co.,Ltd. (4554) timely disclosure | Komori