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Other Disclosures4554Fuji Pharma Co.,Ltd.Pharmaceuticals

Notice of Marketing Approval for “Golimumab Biosimilar 50 mg Subcutaneous Auto-Injector ‘F’” — Expanding the Golimumab Biosimilar Product Lineup

Fuji Pharma Co., Ltd. has obtained marketing approval for an autoinjector formulation, a new administration device for golimumab BS. Reimbursement listing and launch will be possible from May 2027 onward.

Worth reading
62In focus
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Direction
Improvement
Direction inferred from the company’s description.
Scale
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Wording
Conditional
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Announced details

Golimumab BS Subcutaneous Injection 50 mg Autoinjector “F”Golimumab BS subcutaneous injection 50 mg syringe “F”
Applicable field (uses covered by this announcement)
Rheumatoid arthritis inadequately controlled by existing treatments, including prevention of structural joint damageImprovement and maintenance therapy for moderate to severe ulcerative colitis, limited to cases inadequately controlled by existing treatments
Launch dateReimbursement listing and launch possible from May 2027 onward (planned)
Contract Date4 November 2025 (stated as the date the agreement was announced)
Relationship between the counterparty and the company
Fuji Pharma Co.,Ltd.4554
Relationship with the Company

The Company has an agreement with Janssen Biotech, Inc. and Alvotech hf. dated 4 November 2025. Details of the contractual relationship are not disclosed.

CounterpartyJanssen Biotech, Inc.Alvotech hf.

Janssen Biotech, Inc. is based in Pennsylvania, United States. Alvotech hf. is based in Iceland. Other details are not disclosed.

Award/certification name

Marketing approval

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Announced details
ItemDetails
Names of Products / Services CoveredGolimumab BS Subcutaneous Injection 50 mg Autoinjector “F”, Golimumab BS subcutaneous injection 50 mg syringe “F”
CounterpartyJanssen Biotech, Inc., Alvotech hf.
Counterparty overviewJanssen Biotech, Inc. is based in Pennsylvania, United States. Alvotech hf. is based in Iceland. Other details are not disclosed.
Relationship with the CompanyThe Company has an agreement with Janssen Biotech, Inc. and Alvotech hf. dated 4 November 2025. Details of the contractual relationship are not disclosed.
Contract Date4 November 2025 (stated as the date the agreement was announced)
Launch dateReimbursement listing and launch possible from May 2027 onward (planned)
Applicable areaRheumatoid arthritis inadequately controlled by existing treatments, including prevention of structural joint damage, Improvement and maintenance therapy for moderate to severe ulcerative colitis, limited to cases inadequately controlled by existing treatments
Award/certification nameMarketing approval
Items this document does not state (10)
Contract ValueOffering priceAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historyImpact on Business PerformanceSource

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 choice of administration devices alongside the existing syringe formulation, improving patient convenience and meeting the diverse needs of healthcare providers. The Company has positioned its biosimilar business as one of its growth strategies under its medium-term management plan.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice of Marketing Approval for “Golimumab Biosimilar 50 mg Subcutaneous Auto-Injector ‘F’” — Expanding the Golimumab Biosimilar Product Lineup | Fuji Pharma Co.,Ltd. (4554) timely disclosure | Komori