Japan Biosimilar Tracker · トシリズマブ(遺伝子組換え)
Every Tocilizumab biosimilar approved in Japan against Actemra: 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: Actemra (アクテムラ; 中外製薬). ← All biosimilars in Japan
| Approved | Designation | Applicant | Developer (verified) | Product (PMDA English list) |
|---|---|---|---|---|
| 2025-09-19 | tocilizumab biosimilar 1 トシリズマブ後続1 | Celltrion Healthcare Japan | Celltrion [basis] | (1) Tocilizumab BS for Intravenous Infusion 80 mg “CT” (2) Tocilizumab BS for Intravenous Infusion 200 mg “CT” (3) Tocilizumab BS for Intravenous Infusion 400 mg “CT” (4) Tocilizumab BS 162 mg Syringes for S.C. Injection “CT” (5) Tocilizumab BS 162 mg Auto-Iinjector for S.C. Injection “CT” |
| 2026-03-23 | tocilizumab biosimilar 2 トシリズマブ後続2 | Mochida Pharmaceutical | Gedeon Richter (co-developed with Mochida, RGB-19) [basis] |
One row per product and strength. Price ratio = biosimilar NHI price ÷ Actemra NHI price at the identical NHI strength (“–” when no originator has the same strength).
| Product | Strength | Company | Approved | NHI listed | Launch | Price ratio | Status |
|---|---|---|---|---|---|---|---|
| トシリズマブBS点滴静注200mg「CT」 | 200mg10mL1瓶 | Celltrion Healthcare Japan developer: Celltrion | 2025-09-19 | 2025-11-12 company notice | 2026-04-28 | 72% | listed |
| トシリズマブBS点滴静注400mg「CT」 | 400mg20mL1瓶 | Celltrion Healthcare Japan developer: Celltrion | 2025-09-19 | 2025-11-12 company notice | 2026-04-28 | 66% | listed |
| トシリズマブBS点滴静注80mg「CT」 | 80mg4mL1瓶 | Celltrion Healthcare Japan developer: Celltrion | 2025-09-19 | 2025-11-12 company notice | 2026-04-28 | 67% | listed |
| トシリズマブBS点滴静注200mg「MA」 | 200mg10mL1瓶 | Mochida Pharmaceutical developer: Gedeon Richter | 2026-03-23 | 2026-05-20 MHLW NHI list remark | – | 72% | listed |
| トシリズマブBS点滴静注400mg「MA」 | 400mg20mL1瓶 | Mochida Pharmaceutical developer: Gedeon Richter | 2026-03-23 | 2026-05-20 MHLW NHI list remark | – | 66% | listed |
| トシリズマブBS点滴静注80mg「MA」 | 80mg4mL1瓶 | Mochida Pharmaceutical developer: Gedeon Richter | 2026-03-23 | 2026-05-20 MHLW NHI list remark | – | 67% | 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
No NDB figure yet: the first biosimilar was listed after FY2024 (the latest NDB open data covers April 2024 to March 2025).
| Date | Event | Ingredient | Company | Details | Source |
|---|---|---|---|---|---|
| 2026-05-20 | NHI listing | Tocilizumab | Mochida Pharmaceutical (developer: Gedeon Richter) | [tocilizumab biosimilar 2] トシリズマブBS点滴静注80mg「MA」, トシリズマブBS点滴静注200mg「MA」, トシリズマブBS点滴静注400mg「MA」 66%–72% of originator | [source] |
| 2026-04-28 | Launch | Tocilizumab | Celltrion Healthcare Japan | [tocilizumab biosimilar 1] トシリズマブBS点滴静注80mg「CT」, トシリズマブBS点滴静注200mg「CT」, トシリズマブBS点滴静注400mg「CT」 Launch (first Actemra biosimilar on the Japanese market). Launch date 28 Apr 2026 per the company notice. | [source] |
| 2026-03-23 | Approval | Tocilizumab | Mochida Pharmaceutical (developer: Gedeon Richter) | [tocilizumab biosimilar 2] トシリズマブBS点滴静注80mg「MA」, トシリズマブBS点滴静注200mg「MA」, トシリズマブBS点滴静注400mg「MA」… Approval of RGB-19 (Mochida / Gedeon Richter). Mochida supplies, Ayumi Pharmaceutical sells. | [source 1] [source 2] |
| 2025-11-12 | NHI listing | Tocilizumab | Celltrion Healthcare Japan | [tocilizumab biosimilar 1] トシリズマブBS点滴静注80mg「CT」, トシリズマブBS点滴静注200mg「CT」, トシリズマブBS点滴静注400mg「CT」 66%–72% of originator Listed on the NHI price list 12 Nov 2025 (IV 80/200/400 mg). | [source 1] [source 2] |
| 2025-09-19 | Approval | Tocilizumab | Celltrion Healthcare Japan | [tocilizumab 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.