Japan Biosimilar Tracker · ウステキヌマブ(遺伝子組換え)
Every Ustekinumab biosimilar approved in Japan against Stelara: who sells it, when it was approved, listed and launched, its price versus the originator, and uptake.
Last updated: 2026-09-28 · PMDA biosimilar list as of 2026-09
Originator: Stelara (ステラーラ; ヤンセンファーマ). ← All biosimilars in Japan
| Approved | Designation | Applicant | Developer (verified) | Product (PMDA English list) |
|---|---|---|---|---|
| 2023-09-25 | ustekinumab biosimilar 1 ウステキヌマブ後続1 | Fuji Pharma | Alvotech [basis] | Ustekinumab BS 45 mg Syringe for S.C. Injection “F” |
| 2024-12-27 | ustekinumab biosimilar 2 ウステキヌマブ後続2 | Yoshindo | – | Ustekinumab BS 45 mg Syringe for S.C. Injection “YD” |
| 2025-03-27 | ustekinumab biosimilar 3 ウステキヌマブ後続3 | Celltrion Healthcare Japan | Celltrion [basis] | Ustekinumab BS 45 mg Syringes for S.C. Injection “CT” |
| 2025-12-22 | ustekinumab biosimilar 4 ウステキヌマブ後続4 | Nipro | Samsung Bioepis [basis] | Ustekinumab BS Subcutaneous Injection Syringes 45 mg “Nipro” |
| 2026-09-16 | ustekinumab biosimilar 5 ウステキヌマブ後続5 | Meiji Seika Pharma | – |
One row per product and strength. Price ratio = biosimilar NHI price ÷ Stelara NHI price at the identical NHI strength (“–” when no originator has the same strength).
| Product | Strength | Company | Approved | NHI listed | Launch | Price ratio | Status |
|---|---|---|---|---|---|---|---|
| ウステキヌマブBS皮下注45mgシリンジ「F」 | 45mg0.5mL1筒 | Fuji Pharma developer: Alvotech | 2023-09-25 | 2024-05-22 ≈ first seen on the list; between 2024-04-17 and 2024-05-22 | – | 68% | listed |
| ウステキヌマブBS皮下注90mgシリンジ「F」 | 90mg1mL1筒 | Fuji Pharma developer: Alvotech | 2023-09-25 | 2026-05-20 MHLW NHI list remark | – | – | listed |
| ウステキヌマブBS皮下注45mgシリンジ「YD」 | 45mg0.5mL1筒 | Yoshindo Holdings | 2024-12-27 | 2025-05-21 ≈ first seen on the list; between 2025-04-16 and 2025-05-21 | – | 71% | listed |
| ウステキヌマブBS点滴静注130mg「CT」 | 130mg26mL1瓶 | Celltrion Healthcare Japan developer: Celltrion | 2025-03-27 | 2026-05-20 MHLW NHI list remark | 2026-08-20 | 55% | listed |
| ウステキヌマブBS皮下注45mgシリンジ「CT」 | 45mg0.5mL1筒 | Celltrion Healthcare Japan developer: Celltrion | 2025-03-27 | 2025-05-21 ≈ first seen on the list; between 2025-04-16 and 2025-05-21 | – | 67% | listed |
| ウステキヌマブBS皮下注45mgシリンジ「ニプロ」 | 45mg0.5mL1筒 | Nipro developer: Samsung Bioepis | 2025-12-22 | 2026-05-20 MHLW NHI list remark | 2026-05-20 | 68% | listed |
| ウステキヌマブBS皮下注45 mgシリンジ「明治」 | – | Meiji Seika Pharma | 2026-09-16 | – | – | – | approved, not NHI-listed |
Product names are as on the MHLW NHI list (Japanese). Launch dates only where the company published one. Yen prices for every strength and their history: subscribers only
| Fiscal year | Biosimilar volume share | Data |
|---|---|---|
| FY2024 | 0.5% | NDB open data (FY2024) |
own calculation from MHLW NDB open data: biosimilar volume ÷ (biosimilar + reference product), converted to active ingredient, all settings combined. Not an official MHLW figure. DPC-bundled inpatient use is missing and cells under 400 are hidden (counted as 0), so small products are underestimated. Inpatient / outpatient split and value share: subscribers.
| Date | Event | Ingredient | Company | Details | Source |
|---|---|---|---|---|---|
| 2026-09-16 | Approval | Ustekinumab | Meiji Seika Pharma | [ustekinumab biosimilar 5] | [source] |
| 2026-09-02 | Approval | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] ウステキヌマブBS点滴静注130mg「ニプロ」 Approval of the IV 130 mg form (2nd product under the Nipro-Samsung Bioepis partnership). Company plans NHI listing and launch in Nov 2026. (Release dated 3 Sep 2026; approval dated 2 Sep 2026.) | [source] |
| 2026-08-20 | Launch | Ustekinumab | Celltrion Healthcare Japan | [ustekinumab biosimilar 3] ウステキヌマブBS点滴静注130mg「CT」 Launch of the IV 130 mg form (Crohn's disease induction). Launch date 20 Aug 2026 per the company notice. | [source] |
| 2026-05-20 | NHI listing | Ustekinumab | Fuji Pharma (developer: Alvotech) | [ustekinumab biosimilar 1] ウステキヌマブBS皮下注90mgシリンジ「F」 | [source] |
| 2026-05-20 | NHI listing | Ustekinumab | Celltrion Healthcare Japan | [ustekinumab biosimilar 3] ウステキヌマブBS点滴静注130mg「CT」 55% of originator | [source] |
| 2026-05-20 | NHI listing | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] ウステキヌマブBS皮下注45mgシリンジ「ニプロ」 68% of originator | [source] |
| 2026-05-20 | Launch | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] ウステキヌマブBS皮下注45mgシリンジ「ニプロ」 Launch on the day the NHI listing took effect (20 May 2026), per the company release of 19 May 2026. | [source] |
| 2025-12-22 | Approval | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] | [source] |
| 2025-05-21 | NHI listing | Ustekinumab | Yoshindo Holdings | [ustekinumab biosimilar 2] ウステキヌマブBS皮下注45mgシリンジ「YD」 71% of originator | [source] |
| 2025-05-21 | NHI listing | Ustekinumab | Celltrion Healthcare Japan | [ustekinumab biosimilar 3] ウステキヌマブBS皮下注45mgシリンジ「CT」 67% of originator | [source] |
| 2025-03-27 | Approval | Ustekinumab | Celltrion Healthcare Japan | [ustekinumab biosimilar 3] | [source] |
| 2024-12-27 | Approval | Ustekinumab | Yoshindo | [ustekinumab biosimilar 2] | [source] |
| 2024-05-22 | NHI listing | Ustekinumab | Fuji Pharma (developer: Alvotech) | [ustekinumab biosimilar 1] ウステキヌマブBS皮下注45mgシリンジ「F」 68% of originator | [source] |
| 2023-09-25 | Approval | Ustekinumab | Fuji Pharma (developer: Alvotech) | [ustekinumab biosimilar 1] | [source] |
Sources: PMDA “List of approved biosimilars” (as of 2026-09) and MHLW NHI drug price list, used under the Public Data License 1.0 — processed and translated by Japan Pharma Regulatory Brief (unofficial). Uptake figures are our own calculation from MHLW NDB open data. Company facts from each company's official release (linked). See the MHLW terms of use and PMDA's site policy. This page is not made by, affiliated with or endorsed by PMDA or MHLW. The Japanese originals prevail. Information only; not legal, medical or investment advice.
出典：独立行政法人医薬品医療機器総合機構（PMDA）『承認品目一覧（バイオ後続品）』、厚生労働省『薬価基準収載品目リスト』、『後発医薬品の有無に関する情報』、『NDBオープンデータ』、社会保障審議会医療保険部会・中央社会保険医療協議会の資料を加工して Japan Pharma Regulatory Brief が作成
Last built: · data as of 2026-09-28.